Fasting versus continuing tube feeding before procedures for critically ill patients
FEEDS Trial - Fasting Preprocedurally in Enteral Nutrition: Evaluation of Divergent Approaches in Secure Airway
This trial will test whether stopping tube feeding before a procedure or continuing it affects recovery for adults in the ICU on mechanical ventilation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1072 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 19 sites (Palo Alto, California and 18 other locations) |
| Trial ID | NCT06751043 on ClinicalTrials.gov |
What this trial studies
Critically ill adults on mechanical ventilation who receive enteral tube feeding and are scheduled for a non-emergent procedure are randomly assigned to either stop tube feeding at least 8 hours before the procedure (fasting) or to continue tube feeding (not fasting). This is a multicenter, pragmatic, parallel-group randomized non-inferiority trial with assessor blinding that plans to enroll up to 1,072 participants across major U.S. academic centers. The primary outcome is postoperative days alive and free from mechanical ventilation (DAFV), with secondary outcomes including ICU and hospital length of stay, infections, need for organ support, safety events including pulmonary aspiration, and nutritional outcomes. The study will also examine how fasting duration and calorie/protein delivery relate to clinical outcomes.
Who should consider this trial
Good fit: Adults (≥18) admitted to the ICU who are mechanically ventilated with a secured airway, receiving ongoing non‑trophic enteral tube feeding, and scheduled for a non‑emergent procedure that does not require GI preparation or airway change.
Not a fit: Patients who are not mechanically ventilated, not receiving tube feeding, undergoing emergent procedures, undergoing procedures that require gastrointestinal preparation, or with planned removal/replacement of the airway are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the trial could show that continuing tube feeding is safe and preserves nutrition, potentially reducing time on a ventilator and shortening ICU stays.
How similar studies have performed: Elective surgical studies have suggested low aspiration risk with continued feeding, but randomized evidence in mechanically ventilated ICU patients is limited, so this question is relatively novel for this population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Palo Alto, California and 18 other locations
- Stanford Medical Center — Palo Alto, California, United States (Recruiting)
- UCSF Medical Center Parnassus — San Francisco, California, United States (Recruiting)
- University of Colorado Medical Center — Aurora, Colorado, United States (Not_yet_recruiting)
- University of Miami Hospital — Miami, Florida, United States (Not_yet_recruiting)
- McGaw Medical Center of Northwestern — Chicago, Illinois, United States (Recruiting)
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
- University of Maryland Medical Center — Baltimore, Maryland, United States (Not_yet_recruiting)
- Mass General Hospital — Boston, Massachusetts, United States (Recruiting)
- Brigham & Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States (Recruiting)
- University of Minnesota Medical Center — Minneapolis, Minnesota, United States (Recruiting)
- Columbia University Irvine Medical Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- University of Rochester Medical Center — Rochester, New York, United States (Not_yet_recruiting)
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Active_not_recruiting)
- University of Texas Medical Branch — Galveston, Texas, United States (Recruiting)
- UT Health Houston — Houston, Texas, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Alexander Nagrebetsky, MD, MSC — Massachusetts General Hospital
- Study coordinator: Alexander Nagrebetsky, MD, MSC
- Email: anagrebetsky@mgh.harvard.edu
- Phone: 617-724-3292
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.