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| Name | Class |
|---|---|
| Anesthesia Patient Safety Foundation (APSF) | UNKNOWN |
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Perioperative fasting has historically been viewed as a low-risk intervention. However, preliminary data indicate that perioperative loss of nutrition and fluids is likely harmful. This study intends to characterize perioperative fasting practices and their potential effects on clinical outcomes through possible effects on patient well-being (anxiety, hunger, thirst), physiology (hypovolemia, hypotension), perioperative aspiration, etc. The research team hypothesized that in addition to known adverse effects on patients' well-being, prolonged preoperative fasting adversely affects circulating blood volume-related (hypotension, decreased urine output etc.) and glucose metabolism-related (e.g., hypo/hyperglycemia) perioperative physiology. The investigators will also test for an association between the duration of preoperative fasting and the risk of perioperative pulmonary aspiration.
Additional knowledge on the potential adverse effects of preoperative fasting will inform preoperative fasting policies and research interventions that are relevant to hundreds of millions of patients subjected to preoperative/preprocedural fasting worldwide each year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who receive anesthesia care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative fasting | Other | This cohort study assesses the duration of preoperative fasting and its clinical effects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative nausea and vomiting (PONV) | The co-primary outcome of PONV is defined as administration ≥ 1 antiemetic drug within 12 h postoperatively. | 12 hours postoperatively |
| Intraoperative hypotension | The co-primary outcome of intraoperative hypotension is defined as an area under the curve of intraoperative mean arterial pressure <65 mm Hg. | Intraoperative period. |
| Perioperative acute kidney injury (AKI) | The co-primary outcome of perioperative AKI is defined as stage 1 or higher, based on Kidney Disease Improving Global Outcomes criteria (creatinine rise ≥ 0.3 mg/dl within 48 h or ≥ 1.5 times baseline) from postoperative day (POD) 0 until POD 7 | Postoperative days 0 to 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of prolonged preoperative fasting for clear liquids | Incidence of prolonged preoperative fasting for clear liquids is defined as fasting that exceeds the American Society of Anesthesiologists-recommended duration by a factor of 2 or more (≥ 4 hours). | 48 hours preoperatively |
| Severity of prolonged clear liquid fasting |
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcome: Perioperative pulmonary aspiration | Perioperative pulmonary aspiration is defined as a clinical case of pulmonary aspiration confirmed either bronchoscopically (within 24h), radiologically (within 24h), or by visualization of aspirate in the airway/hypopharynx. | Intraoperative period to 24 hours postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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We will include all anesthesia cases at participating institutions.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Nagrebetsky, MD, MSc | Contact | 617-724-3292 | anagrebetsky@mgh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mass General Brigham Hospital Network of secondary, tertiary, and quaternary care hospitals | Recruiting | Boston | Massachusetts | 02114 | United States |
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Severity of prolonged clear liquid fasting is defined as the frequency of fasting duration that exceeds the currently recommended by 2x, 4x, 6x, etc. |
| 48 hours preoperatively |
| Perioperative hypoglycemia | Perioperative hypoglycemia: any blood glucose concentration < 70 mg/dL from 12 h before to 24 h after the procedure | 12 hours preoperatively to 24 hours postoperatively |
| Perioperative hyperglycemia | Perioperative hyperglycemia is defined as any blood glucose concentration > 140 mg/dL from 12 h before to 24 h after the procedure. | 12 hours preoperatively to 24 hours postoperatively |
| Perioperative AKI stage 2 or higher. | Perioperative AKI stage 2 or higher is defined as creatinine at least twice the baseline level between POD0 to POD7. | Postoperative days 0 to 7 |
| Myocardial injury after noncardiac surgery (MINS) | Myocardial injury after noncardiac surgery is defined as increased cardiac troponin I above the 99th percentile within 3 days after surgery. | Postoperative day 0 to 3 |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
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