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.
Study Type
OBSERVATIONAL
Enrollment
1,200,000
This cohort study assesses the duration of preoperative fasting and its clinical effects
Mass General Brigham Hospital Network of secondary, tertiary, and quaternary care hospitals
Boston, Massachusetts, United States
RECRUITINGPostoperative nausea and vomiting (PONV)
The co-primary outcome of PONV is defined as administration ≥ 1 antiemetic drug within 12 h postoperatively.
Time frame: 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.
Time frame: 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
Time frame: Postoperative days 0 to 7
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).
Time frame: 48 hours preoperatively
Severity of prolonged clear liquid fasting
Severity of prolonged clear liquid fasting is defined as the frequency of fasting duration that exceeds the currently recommended by 2x, 4x, 6x, etc.
Time frame: 48 hours preoperatively
Perioperative hypoglycemia
Perioperative hypoglycemia: any blood glucose concentration \< 70 mg/dL from 12 h before to 24 h after the procedure
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Postoperative day 0 to 3
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