| Primary | Postoperative Acute Kidney Injury | Postoperative Acute Kidney Injury (AKI), Stage I or higher according to the KDIGO criteria (Kidney Disease: Improving Global Outcomes). The staging will be based on serum creatinine values, as documentation of urine output is probably not sufficiently accurate. This will be the primary outcome for the Vanderbilt University Medical Center. The creatinine measurements are part of routine clinical care. Therefore, absence of creatinine postoperative measurements are considered to be 'no suspicion of kidney injury'. KDIGO defines AKI as any of the following: Increase in serum creatinine by 0.3mg/dL or more within 48 hours or Increase in serum creatinine to 1.5 times baseline or more within the last 7 days or Urine output less than 0.5 mL/kg/h for 6 hours. Stage 1 is 1.5-9x baseline or >0.3 increase; Stage 2 is 2-2.9x baseline; Stage 3 is 3x baseline, or increase to > 4, or initiation of renal replacement therapy. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Count of Participants | | Participants | | Within 7 days after surgery | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| AKI stage I or greater | | | No AKI - Confirmed by measurement | |
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| Secondary | 30-day Mortality | Vanderbilt University Medical Center: combination of in-hospital mortality and 'alive-index' (which checks for visits to the hospital in the electronic healthcare record as indication of being alive at 30 days) | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). For a large group of patients no mortality information was available. | Posted | | Count of Participants | | Participants | | 30 days after surgery | | | | ID | Title | Description |
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| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
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| Secondary | In-hospital Mortality | Hospital mortality rate during a single hospital admission after the surgery | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Count of Participants | | Participants | | All postoperative days during a single hospital admission, expected median of 5 days | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
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| Secondary | Postoperative Acute Kidney Injury Stage 2 | Postoperative Acute Kidney Injury (AKI), Stage II or higher according to the KDIGO criteria (Kidney Disease: Improving Global Outcomes). The staging will be based on serum creatinine values, as documentation of urine output is probably not sufficiently accurate. The creatinine measurements are part of routine clinical care. Therefore, absence of creatinine postoperative measurements are considered to be 'no suspicion of kidney injury'. KDIGO defines AKI as any of the following: Increase in serum creatinine by 0.3mg/dL or more within 48 hours or Increase in serum creatinine to 1.5 times baseline or more within the last 7 days or Urine output less than 0.5 mL/kg/h for 6 hours. Stage 1 is 1.5-9x baseline or >0.3 increase; Stage 2 is 2-2.9x baseline; Stage 3 is 3x baseline, or increase to > 4, or initiation of renal replacement therapy. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Count of Participants | | Participants | | Within 7 days after surgery | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | |
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| Secondary | Postoperative Rise in Creatinine Levels | Absolute values for serum creatinine before and after surgery will be compared. When multiple postoperative creatinine measurements are made, the maximum difference is reported. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). Patients with no routine postoperative creatinine measurements are excluded from the analysis. | Posted | | Median | Inter-Quartile Range | mg/dL | | Within 7 days after surgery | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
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| Secondary | Incidence of a MAP < 60 mmHg | Incidence of a mean arterial pressure (MAP) < 60 mmHg during anesthesia for 1 minute or more. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Count of Participants | | Participants | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
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| Secondary | Incidence of a MAP < 55 mmHg | Incidence of a mean arterial pressure (MAP) < 55 mmHg during anesthesia for 1 minute or more. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Count of Participants | | Participants | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
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| Secondary | Incidence of a MAP < 50 mmHg | Incidence of a mean arterial pressure (MAP) < 50 mmHg during anesthesia for 1 minute or more. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Count of Participants | | Participants | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
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| Secondary | Incidence of a MAP < 60 mmHg for > 10 Minutes | Incidence of a mean arterial pressure (MAP) < 60 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Count of Participants | | Participants | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Incidence of a MAP < 55 mmHg for > 10 Minutes | Incidence of a mean arterial pressure (MAP) < 55 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Count of Participants | | Participants | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
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| Secondary | Incidence of a MAP < 50 mmHg for > 10 Minutes | Incidence of a mean arterial pressure (MAP) < 50 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Count of Participants | | Participants | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
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| Secondary | Incidence of a MAP < 60 mmHg for > 20 Minutes | Incidence of a mean arterial pressure (MAP) < 60 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Count of Participants | | Participants | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Incidence of a MAP < 55 mmHg for > 20 Minutes | Incidence of a mean arterial pressure (MAP) < 55 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Count of Participants | | Participants | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
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| Secondary | Incidence of a MAP < 50 mmHg for > 20 Minutes | Incidence of a mean arterial pressure (MAP) < 50 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Count of Participants | | Participants | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
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| Secondary | Depth and Duration of Intraoperative Hypotension - Threshold MAP 75 mmHg | Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Median | Inter-Quartile Range | mmHg*minute | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Depth and Duration of Intraoperative Hypotension - Threshold MAP 70 mmHg | Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Median | Inter-Quartile Range | mmHg*minute | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Depth and Duration of Intraoperative Hypotension - Threshold MAP 65 mmHg | Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Median | Inter-Quartile Range | mmHg*minute | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Depth and Duration of Intraoperative Hypotension - Threshold MAP 60 mmHg | Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Median | Inter-Quartile Range | mmHg*minute | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Depth and Duration of Intraoperative Hypotension - Threshold MAP 55 mmHg | Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Median | Inter-Quartile Range | mmHg*minute | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
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| Secondary | Depth and Duration of Intraoperative Hypotension - Threshold MAP 50 mmHg | Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Median | Inter-Quartile Range | mmHg*minute | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
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| Secondary | Estimated Intraoperative Blood Loss | The estimated blood loss in mL during the surgical procedure | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Median | Inter-Quartile Range | mL | | During the surgical procedure: an expected average of 2 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Time to Discharge Readiness at the Postanesthesia Care Unit (PACU) | The time from arriving at the postanesthesia care unit (PACU) until the time the patient is considered ready for discharge (in minutes). | Only patients with a postoperative stay at the postanesthesia care unit (PACU). Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Median | Inter-Quartile Range | minutes | | A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU, an expected average of 4 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg | Average concentrations of propofol infusion rates during MAP < 65 mmHg episodes | All patients with any MAP < 65 mmHg and a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed. | Posted | | Median | Inter-Quartile Range | mcg/kg/min (propofol) | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg | Average concentrations of propofol infusion rates during MAP < 60 mmHg episodes | All patients with any MAP < 60 mmHg and either a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed. | Posted | | Median | Inter-Quartile Range | mcg/kg/min (propofol) | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg | Average concentrations of propofol infusion rates during MAP < 55 mmHg episodes | All patients with any MAP < 55 mmHg and either a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed. | Posted | | Median | Inter-Quartile Range | mcg/kg/min (propofol) | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg | Average concentrations of propofol infusion rates during MAP < 50 mmHg episodes | All patients with any MAP < 50 mmHg and a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed. | Posted | | Median | Inter-Quartile Range | mcg/kg/min (propofol) | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Average Use of Cardiovascular Drugs: Ephedrine | Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosages would be meaningless. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). In addition, only patients that actually received any ephedrine are analyzed. | Posted | | Median | Inter-Quartile Range | mg | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Average Use of Cardiovascular Drugs: Phenylephrine | Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). In addition, only patients that actually received any phenylephrine are analyzed. | Posted | | Median | Inter-Quartile Range | mg | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Average Use of Cardiovascular Drugs: Glycopyrrolate | Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). In addition, only patients that actually received any glycopyrrolate are analyzed. | Posted | | Median | Inter-Quartile Range | mg | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Average Use of Cardiovascular Drugs: Epinephrine | Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). In addition, only patients that actually received any epinephrine are analyzed. | Posted | | Median | Inter-Quartile Range | mg | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Average Use of Cardiovascular Drugs: Norepinephrine | Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). In addition, only patients that actually received any norepinephrine are analyzed. | Posted | | Median | Inter-Quartile Range | mg | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Timing of Cardiovascular Drugs for MAP < 65 mmHg | Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 60 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. | All patients with any MAP < 65 mmHg and an administration event of a cardiovascular drugs within 5 minutes before the start of the hypotensive episode (the first value below 65 mmHg) and 15 minutes after the start of the episode. | Posted | | Median | Inter-Quartile Range | minutes | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Timing of Cardiovascular Drugs for MAP < 60 mmHg | Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 60 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. | All patients with any MAP < 60 mmHg and an administration event of a cardiovascular drugs within 5 minutes before the start of the hypotensive episode (the first value below 60 mmHg) and 15 minutes after the start of the episode. | Posted | | Median | Inter-Quartile Range | minutes | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Timing of Cardiovascular Drugs for MAP < 55 mmHg | Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 55 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. | All patients with any MAP < 55 mmHg and an administration event of a cardiovascular drugs within 5 minutes before the start of the hypotensive episode (the first value below 55 mmHg) and 15 minutes after the start of the episode. | Posted | | Median | Inter-Quartile Range | minutes | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Timing of Cardiovascular Drugs for MAP < 50 mmHg | Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 50 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP. | All patients with any MAP < 50 mmHg and an administration event of a cardiovascular drugs within 5 minutes before the start of the hypotensive episode (the first value below 50 mmHg) and 15 minutes after the start of the episode. | Posted | | Median | Inter-Quartile Range | minutes | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Secondary | Intraoperative Administration of Intravenous Fluids | Total amount (mL) of intravenous fluids (as defined under interventions) administered during the surgical procedure. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Median | Inter-Quartile Range | mL | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Post-Hoc | Postoperative Acute Kidney Injury | Postoperative Acute Kidney Injury (AKI), Stage I or higher according to the KDIGO criteria (Kidney Disease: Improving Global Outcomes). The staging will be based on serum creatinine values, as documentation of urine output is probably not sufficiently accurate. This will be the primary outcome for the Vanderbilt University Medical Center. The creatinine measurements are part of routine clinical care. Therefore, absence of creatinine postoperative measurements are considered to be 'no suspicion of kidney injury'. KDIGO defines AKI as any of the following: Increase in serum creatinine by 0.3mg/dL or more within 48 hours or Increase in serum creatinine to 1.5 times baseline or more within the last 7 days or Urine output less than 0.5 mL/kg/h for 6 hours. Stage 1 is 1.5-9x baseline or >0.3 increase; Stage 2 is 2-2.9x baseline; Stage 3 is 3x baseline, or increase to > 4, or initiation of renal replacement therapy. | Post-Hoc analysis: all patients, not only those with any MAP < 65 mmHg. | Posted | | Count of Participants | | Participants | | Within 7 days after surgery | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | |
|
| Post-Hoc | Usage Frequency of Cardiovascular Drugs: Ephedrine | Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Count of Participants | | Participants | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Post-Hoc | Usage Frequency of Cardiovascular Drugs: Phenylephrine | Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Count of Participants | | Participants | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Post-Hoc | Usage Frequency of Cardiovascular Drugs: Glycopyrrolate | Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Count of Participants | | Participants | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
|
| Post-Hoc | Usage Frequency of Cardiovascular Drugs: Ephinephrine | Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Count of Participants | | Participants | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
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| Post-Hoc | Usage Frequency of Cardiovascular Drugs: Norepinephrine | Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported. | Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). | Posted | | Count of Participants | | Participants | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
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| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
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| Secondary | Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg | Average concentrations of inhalational anesthesia during MAP < 65 mmHg episodes | All patients with any MAP < 65 mmHg and a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed. | Posted | | Median | Inter-Quartile Range | EndTidal% (other) | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
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| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
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| Secondary | Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg | Average concentrations of inhalational anesthesia during MAP < 60 mmHg episodes | All patients with any MAP < 60 mmHg and either a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed. | Posted | | Median | Inter-Quartile Range | EndTidal% (other) | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
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| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
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| Secondary | Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg | Average concentrations of inhalational anesthesia during MAP < 55 mmHg episodes | All patients with any MAP < 55 mmHg and either a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed. | Posted | | Median | Inter-Quartile Range | EndTidal% (other) | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
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| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
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| Secondary | Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg | Average concentrations of inhalational anesthesia during MAP < 50 mmHg episodes | All patients with any MAP < 50 mmHg and a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed. | Posted | | Median | Inter-Quartile Range | EndTidal% (other) | | During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours | | | | ID | Title | Description |
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| OG000 | Usual Care Group | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). | | OG001 | Hypotension Decision Support | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
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