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This study evaluates whether using information from a special arterial blood pressure monitor to guide how much fluid is given during surgery changes how long a patient stays in the hospital after the surgery. There is scientific evidence from using similar information from different devices that this technique might allow us to do a better job giving fluids during surgery and that this may be associated with shorter hospital stay after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard fluid management | No Intervention | standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team | |
| Goal directed therapy | Experimental | Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vigileo | Device | Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Postoperative Hospital Stay | time in days from end of surgery to hospital discharge | within one month |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery Score on Postoperative Day 2 | Measure of quality of recovery (QOR) using scoring system in 9 domains as assessed by patient and nursing team. Score for each domain is assigned as 0, 1 or 2; the sum of scores is the QOR score with a range of 0 to 18. Higher scores indicate better quality of recovery after surgery. | Postoperative day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard L. Applegate II, MD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92354 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Fluid Management | Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team |
| FG001 | Goal Directed Therapy | Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Fluid Management | Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team |
| BG001 | Goal Directed Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Length of Postoperative Hospital Stay | time in days from end of surgery to hospital discharge | Posted | Mean | Full Range | Days | within one month |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Fluid Management |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tonya Hamilton | Loma Linda University | 909-558-9408 | thamilton@llu.edu |
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|
| Quality of Recovery Score on Postoperative Day 4 | Measure of quality of recovery (QOR) using scoring system in 9 domains as assessed by patient and nursing team. Score for each domain is assigned as 0, 1 or 2; the sum of scores is the QOR score with a range of 0 to 18. Higher scores indicate better quality of recovery following surgery. | Postoperative day 4 |
| Physician Decision |
|
Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis
Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
|
| Secondary | Quality of Recovery Score on Postoperative Day 2 | Measure of quality of recovery (QOR) using scoring system in 9 domains as assessed by patient and nursing team. Score for each domain is assigned as 0, 1 or 2; the sum of scores is the QOR score with a range of 0 to 18. Higher scores indicate better quality of recovery after surgery. | Posted | Median | Inter-Quartile Range | units on a scale | Postoperative day 2 |
|
|
|
| Secondary | Quality of Recovery Score on Postoperative Day 4 | Measure of quality of recovery (QOR) using scoring system in 9 domains as assessed by patient and nursing team. Score for each domain is assigned as 0, 1 or 2; the sum of scores is the QOR score with a range of 0 to 18. Higher scores indicate better quality of recovery following surgery. | Posted | Median | Inter-Quartile Range | units on a scale | Postoperative day 4 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Goal Directed Therapy | 0 | 18 | 0 | 18 |
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