Fasting versus continuing tube feeding before procedures for critically ill patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Stanford Medical Center
  Palo Alto, California, United States Recruiting
• UCSF Medical Center Parnassus
  San Francisco, California, United States Recruiting
• McGaw Medical Center of Northwestern
  Chicago, Illinois, United States Recruiting
• Rush University Medical Center
  Chicago, Illinois, United States Recruiting
• Mass General Hospital
  Boston, Massachusetts, United States Recruiting
• Brigham & Women's Hospital
  Boston, Massachusetts, United States 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.