About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnostic or therapeutic procedure with anesthesia care (general anesthesia, regional anesthesia, sedation, or a combination of the above)
Disqualifiers
Not receiving anesthesia care
Lack of medical record data in Epic electronic medical record system
Trial population
We will include all anesthesia cases at participating institutions.
Trial design
Cohort
Other
Treatments tested in this trial
Preoperative fasting
Other interventionThis cohort study assesses the duration of preoperative fasting and its clinical effects
Treatment groups
Trial outcomes
Primary outcomes
Postoperative nausea and vomiting (PONV)
The co-primary outcome of PONV is defined as administration ≥ 1 antiemetic drug within 12 h 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.
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
Secondary outcomes
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).
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.
Perioperative hypoglycemia
Perioperative hypoglycemia: any blood glucose concentration \< 70 mg/dL from 12 h before to 24 h after the procedure
Perioperative hyperglycemia
Perioperative hyperglycemia is defined as any blood glucose concentration \> 140 mg/dL from 12 h before to 24 h after the procedure.
Other outcomes
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.
Sponsors and contacts
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Massachusetts General Hospital
Lead sponsor
Anesthesia Patient Safety Foundation (APSF)
Collaborator