The Million Anesthesia Cases Study (MACS) - a Cohort Study of Preoperative Fasting and Perioperative Outcomes

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMassachusetts General Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Preoperative fasting

    Other intervention

    This cohort study assesses the duration of preoperative fasting and its clinical effects

Treatment groups

1,200,000 Participants
are divided into 1 treatment group
Group A: Patients who receive anesthesia care1 intervention

Trial outcomes

Primary outcomes

1

Postoperative 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
2

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.
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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.

Time frame
Intraoperative period to 24 hours postoperatively

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Anesthesia Patient Safety Foundation (APSF)

Collaborator