Preoperative Fasting vs. Not Fasting in Critically Ill Patients

Recruiting now · Not applicable

Conditions studied: Critical Illness, Surgical Procedure, Unspecified, Pulmonary Aspiration, Fasting

In brief

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. * Data from routine electronic medical records will be reviewed to determine how participants are doing 3 months after their procedure. '

Key facts

Study ID

NCT06751043

Run by

Massachusetts General Hospital

People needed

1072

Starts

2025-04-28

Expected to finish

2028-05-01

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Age ≥ 18
• Current admission to ICU*
• Secure airway** with no plans for its removal prior to procedure
• Current non-trophic (> 10 mL/hr) tube (enteral) feeding*** with no plans to discontinue prior to procedure for reasons other than preoperative fasting
• Planned eligible procedure (Examples are listed in Appendix C) with anesthesia care or nursing sedation. Eligible procedures are defined as non-emergent diagnostic or therapeutic interventions that:
• Do NOT have a well-established practice of preoperative fasting. (For example, bedside placement of a vascular catheter [arterial, central venous, peripheral venous] by the ICU team is NOT eligible for this trial since it has a widely established practice of no preoperative fasting and is not generally scheduled for a specific time.)
• Do NOT require fasting for preoperative gastrointestinal tract preparation
• Do NOT require removal/replacement of the endotracheal or tracheostomy tube
• Do NOT require prone or Trendelenburg (head-down) positioning.
• Typically require procedural sedation or anesthesia care.
• Generally, are scheduled for a specific time (although this time can change, or procedure may be cancelled).
• Are performed in the operating room, non-operating room procedural areas, or at the patient's bedside.
• All ICU types are eligible: surgical, medical, cardiac, neurological, trauma, mixed etc.
• Secure airway is defined as a cuffed endotracheal tube or a cuffed tracheostomy tube.
• Patients with all types of feeding tubes are eligible, regardless of tube insertion site (nasal, oral, surgically implanted) and tube tip location (pre- and post-pyloric) †As determined by the enrolling physician-investigator

You may not qualify if…

• Inability to obtain informed consent
• Inability to enroll and randomize > 8 hours prior to planned procedure time
• Inability to deliver trial interventions
• Expected survival < 48 hours as determined by the enrolling physician-investigator
• Critically ill burn patient
• Emergency procedure
• a. Gastrointestinal tract procedure that requires fasting based on surgical indications or b. airway/lung procedure that requires removal of endotracheal or tracheostomy tube
• Plan for prone or Trendelenburg (head down) positioning during most of the procedure
• Major impairment of gastrointestinal motility or major structural disease of the gastrointestinal tract (e.g., severe gastroparesis, bowel obstruction, severe ileus, severely compromised lower esophageal sphincter, active gastrointestinal bleeding)
• Plan for postoperative extubation in the procedure area
• Prisoner
• Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test during the current hospitalization, or woman who is breast feeding
• Refusal to enroll patient by treating physician
• Extracorporeal Membrane Oxygenation (ECMO) at the time of potential enrollment, except patients scheduled for ECMO decannulation as the study procedure and patients expected to be off of ECMO at the time of study procedure.
• Chronic mechanical ventilation at pre-admission level of care

Where it is running

• Stanford Medical Center — Palo Alto, California, United States (enrolling)
• UCSF Medical Center Parnassus — San Francisco, California, United States (enrolling)
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States (enrolling)
• Columbia University Irvine Medical Center — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (enrolling)
• University of Texas Medical Branch — Galveston, Texas, United States (enrolling)
• McGaw Medical Center of Northwestern — Chicago, Illinois, United States (enrolling)
• Rush University Medical Center — Chicago, Illinois, United States (enrolling)
• Mass General Hospital — Boston, Massachusetts, United States (enrolling)
• Brigham & Women's Hospital — Boston, Massachusetts, United States (enrolling)
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States (enrolling)
• University of Colorado Medical Center — Aurora, Colorado, United States
• University of Miami Hospital — Miami, Florida, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• UT Health Houston — Houston, Texas, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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