Recruiting

Fasting vs. Not Fasting

Sponsor:

Massachusetts General Hospital

Code:

NCT06751043

Conditions

Critical Illness

Surgical Procedure, Unspecified

Pulmonary Aspiration

Fasting

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fasting

Not fasting

Study Details

Brief 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.

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

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Conditions

Critical Illness

Surgical Procedure, Unspecified

Pulmonary Aspiration

Fasting

Study ID

NCT06751043

Start date

Apr 28, 2025

Status verified date

Jun, 2026

Completion date

May, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1072 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Fasting

Patients randomized to the Fasting arm will have tube feeding stopped at least 8 hours before the scheduled surgery or procedure time.

active comparator: Not Fasting

Patients randomized to the Not Fasting arm will have tube feeding continued until transfer to the operating room/procedure area.

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.

Primary outcome measure

  • Days alive and free from mechanical ventilation on postoperative day 28. [ Time Frame: Post-operative day 28 ]

Central Contacts and Locations

Central contacts

Alexander Nagrebetsky, MD, MSC

617-724-3292anagrebetsky@mgh.harvard.edu

Locations

Stanford Medical Center

Recruiting

Palo Alto, California, United States, 94305

Contacts

Pedro Tanaka, MD, PhD, MACM

(650) 498-6000ptanaka@stanford.edu

UCSF Medical Center Parnassus

Recruiting

San Francisco, California, United States, 94143

Contacts

McGaw Medical Center of Northwestern

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Ravindra Gupta, MD, FASA, FCCP

(312) 503-7975Ravindra.Gupta@nm.org

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Mass General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Brigham & Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

University of Massachusetts Memorial Medical Center

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

University of Minnesota Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Columbia University Irvine Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Vivek Moitra, MD, FASA, FCCP

(212) 305-2500vm2161@cumc.columbia.edu

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Ashish Khanna, MD, FCCP, FCCM

336-758-5000akhanna@wakehealth.edu

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

Contacts

Marcos Vidal Melo, MD, PhD

409-772-1011mfvidalm@UTMB.EDU

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • pulmonary aspiration
  • enteral nutrition
  • tube feeding
  • preoperative fasting
  • perioperative medicine
  • surgery in critically ill
  • procedures in critically ill
  • nutrition in critical illness
  • perioperative safety
  • preoperative management
  • preoperative fasting in secure airway
  • anesthesia in critically ill

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-06-12.