NCT07022951 The Million Anesthesia Cases Study (MACS) - a Cohort Study of Preoperative Fasting and Perioperative Outcomes
| NCT ID | NCT07022951 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Anesthesia |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200,000 participants |
| Start Date | 2016-01-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,200,000 participants in total. It began in 2016-01-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * Diagnostic or therapeutic procedure with anesthesia care (general anesthesia, regional anesthesia, sedation, or a combination of the above) Exclusion Criteria: * Not receiving anesthesia care * Lack of medical record data in Epic electronic medical record system
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07022951 clinical trial?
This trial is open to participants of all sexes, studying Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07022951 currently recruiting?
Yes, NCT07022951 is actively recruiting participants. Contact the research team at anagrebetsky@mgh.harvard.edu for enrollment information.
Where is the NCT07022951 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07022951 clinical trial?
NCT07022951 is sponsored by Massachusetts General Hospital. The trial plans to enroll 1,200,000 participants.