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To fast or not to fast? major trial tests Tube-Feeding timing in ICU

NCT ID NCT06751043

Knowledge-focused Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether stopping tube feeding for at least 8 hours before a procedure helps or harms recovery in critically ill patients on breathing machines. About 1,072 adults in the ICU will be randomly assigned to either fast or continue feeding until right before their procedure. Researchers will track lung complications, hospital stays, and survival to see which approach is safer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,072 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

aspiration pneumonia Critical Illness Fasting

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Critical illness Fasting Pulmonary aspiration Surgical procedure, unspecified

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brigham & Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Cleveland Clinic

    ACTIVE_NOT_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University Irvine Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Mass General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • McGaw Medical Center of Northwestern

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Stanford Medical Center

    RECRUITING

    Palo Alto, California, 94305, United States

  • UCSF Medical Center Parnassus

    RECRUITING

    San Francisco, California, 94143, United States

  • UT Health Houston

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • University of Colorado Medical Center

    NOT_YET_RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Maryland Medical Center

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Massachusetts Memorial Medical Center

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University of Miami Hospital

    NOT_YET_RECRUITING

    Miami, Florida, 33136, United States

  • University of Minnesota Medical Center

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Rochester Medical Center

    NOT_YET_RECRUITING

    Rochester, New York, 14642, United States

  • University of Texas Medical Branch

    RECRUITING

    Galveston, Texas, 77555, United States

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

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