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Preoperative Fasting vs. Not Fasting in Critically Ill Patients

Recruiting

FEEDS Trial - Fasting Preprocedurally in Enteral Nutrition: Evaluation of Divergent Approaches in Secure Airway

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

1. 1\. Age ≥ 18
2. Current admission to ICU\*
3. Secure airway\*\* with no plans for its removal prior to procedure
4. Current non-trophic (\> 10 mL/hr) tube (enteral) feeding\*\*\* with no plans to discontinue prior to procedure for reasons other than preoperative fasting
5. 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

Exclusion Criteria

1. Inability to obtain informed consent
2. Inability to enroll and randomize \> 8 hours prior to planned procedure time
3. Inability to deliver trial interventions
4. Expected survival \< 48 hours as determined by the enrolling physician-investigator
5. Critically ill burn patient
6. Emergency procedure
7. a. Gastrointestinal tract procedure that requires fasting based on surgical indications or b. airway/lung procedure that requires removal of endotracheal or tracheostomy tube
8. Plan for prone or Trendelenburg (head down) positioning during most of the procedure
9. 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)
10. Plan for postoperative extubation in the procedure area
11. Prisoner
12. 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
13. Refusal to enroll patient by treating physician
14. 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.
15. Chronic mechanical ventilation at pre-admission level of care

About the study

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.

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What is being tested

Sponsor: Massachusetts General Hospital · Participants: 1,072 · Started: Apr 28, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06751043

Locations in the U.S.

CaliforniaStanford Medical Center, Palo Alto
UCSF Medical Center Parnassus, San Francisco
ColoradoUniversity of Colorado Medical Center, Aurora (Not yet recruiting)
FloridaUniversity of Miami Hospital, Miami (Not yet recruiting)
IllinoisMcGaw Medical Center of Northwestern, Chicago
Rush University Medical Center, Chicago
MarylandUniversity of Maryland Medical Center, Baltimore (Not yet recruiting)
MassachusettsBrigham & Women's Hospital, Boston
Mass General Hospital, Boston
University of Massachusetts Memorial Medical Center, Worcester
MinnesotaUniversity of Minnesota Medical Center, Minneapolis
New YorkColumbia University Irvine Medical Center, New York
Memorial Sloan Kettering Cancer Center, New York
University of Rochester Medical Center, Rochester (Not yet recruiting)
Montefiore Medical Center, The Bronx
North CarolinaWake Forest University Health Sciences, Winston-Salem
TexasUniversity of Texas Medical Branch, Galveston
UT Health Houston, Houston (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.