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Preoperative Fasting vs. Not Fasting in Critically Ill Patients
Sponsor: Massachusetts General Hospital
Summary
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. '
Official title: FEEDS Trial - Fasting Preprocedurally in Enteral Nutrition: Evaluation of Divergent Approaches in Secure Airway
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1072
Start Date
2025-04-28
Completion Date
2028-05
Last Updated
2026-01-30
Healthy Volunteers
No
Interventions
Fasting
Process: Fasting pre-procedure Tube feeding will be stopped at least 8 hours before the patient's scheduled surgery or procedure time.
Not fasting
Process: Not fasting pre-procedure Tube feeding will be continued until patient transfer to the operating room/procedure area.
Locations (19)
Stanford Medical Center
Palo Alto, California, United States
UCSF Medical Center Parnassus
San Francisco, California, United States
University of Colorado Medical Center
Aurora, Colorado, United States
University of Miami Hospital
Miami, Florida, United States
McGaw Medical Center of Northwestern
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Mass General Hospital
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Columbia University Irvine Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Texas Medical Branch
Galveston, Texas, United States
UT Health Houston
Houston, Texas, United States