Actively Recruiting
Preoperative Fasting vs. Not Fasting in Critically Ill Patients
Led by Massachusetts General Hospital · Updated on 2026-01-30
1072
Participants Needed
19
Research Sites
157 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if fasting or not fasting before a procedure has an effect on recovery in those who are critically ill. The main questions it aims to answer for patients on a breathing machine who are receiving tube feeding are: * Does the risk of lung complications and death differ between those who are not fasting, which may have a higher chance of allowing tube feeding to enter the lungs, and fasting, which temporarily stops nutrition before a procedure? * Is there a difference in recovery times, hospital stays, infection rates, need for organ support, safety, and nutrition for those who either fast or do not fast before a procedure? * What is the relationship between nutrition and clinical outcomes? Researchers will compare not fasting and fasting to see if it has an effect on recovery. Participants will: * Be assigned by chance (like a coin toss) to one of two groups. One group (fasting group) will have their tube feeding stopped at least 8 hours before their procedure. The other group (not fasting group) will have their tube feeding stopped right before their procedure. * Be monitored via medical record for amount of protein and calories received, and any complications related to fasting/not fasting. * Receive a phone call from the study team about 3 months after they enter the study to see how they are doing and complete a questionnaire. '
CONDITIONS
Official Title
Preoperative Fasting vs. Not Fasting in Critically Ill Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Currently admitted to an ICU
- Have a secure airway (cuffed endotracheal or tracheostomy tube) with no plans to remove it before the procedure
- Receiving non-trophic tube feeding (more than 10 mL per hour) with no plans to stop it before the procedure except for fasting
- Scheduled for a non-emergency diagnostic or therapeutic procedure that requires sedation or anesthesia and is planned for a specific time
- Procedures do not require fasting for gastrointestinal preparation
- Procedures do not require removal or replacement of airway tubes
- Procedures do not require prone or Trendelenburg positioning
- Procedures may be performed in operating room, other procedural areas, or at bedside
- All ICU types are eligible
- Feeding tubes of all insertion sites and tip locations are eligible
You will not qualify if you...
- Unable to provide informed consent
- Unable to enroll and randomize more than 8 hours before the planned procedure
- Unable to receive trial interventions
- Expected survival less than 48 hours
- Critically ill burn patients
- Emergency procedures
- Gastrointestinal or airway procedures requiring fasting or airway tube removal
- Plan for prone or Trendelenburg positioning during the procedure
- Major gastrointestinal motility impairment or structural disease
- Planned extubation in the procedure area
- Prisoners
- Pregnant or breastfeeding women, or women of childbearing potential without a documented negative pregnancy test
- Treating physician refuses patient enrollment
- On extracorporeal membrane oxygenation (ECMO) at enrollment time except for ECMO decannulation or expected off ECMO at procedure
- Chronic mechanical ventilation at pre-admission care level
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 19 locations
1
Stanford Medical Center
Palo Alto, California, United States, 94305
Actively Recruiting
2
UCSF Medical Center Parnassus
San Francisco, California, United States, 94143
Actively Recruiting
3
University of Colorado Medical Center
Aurora, Colorado, United States, 80045
Not Yet Recruiting
4
University of Miami Hospital
Miami, Florida, United States, 33136
Not Yet Recruiting
5
McGaw Medical Center of Northwestern
Chicago, Illinois, United States, 60611
Actively Recruiting
6
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
7
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Not Yet Recruiting
8
Mass General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
10
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Actively Recruiting
11
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
12
Columbia University Irvine Medical Center
New York, New York, United States, 10032
Actively Recruiting
13
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
14
University of Rochester Medical Center
Rochester, New York, United States, 14642
Not Yet Recruiting
15
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
16
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
17
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Active, Not Recruiting
18
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Actively Recruiting
19
UT Health Houston
Houston, Texas, United States, 77030
Not Yet Recruiting
Research Team
A
Alexander Nagrebetsky, MD, MSC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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