NCT06751043 · Massachusetts General Hospital
Preoperative Fasting vs. Not Fasting in Critically Ill Patients
(FEEDS)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 1\. Age ≥ 18
- Current admission to ICU\
- Secure airway\*\
- with no plans for its removal prior to procedure
- Current non-trophic (\> 10 mL/hr) tube (enteral) feeding\*\*\
- with no plans to discontinue prior to procedure for reasons other than preoperative fasting
- 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
- Inability to obtain informed consent
- Inability to enroll and randomize \> 8 hours prior to planned procedure time
- Inability to deliver trial interventions
- Expected survival \< 48 hours as determined by the enrolling physician-investigator
- Critically ill burn patient
- Emergency procedure
- a. Gastrointestinal tract procedure that requires fasting based on surgical indications or b. airway/lung procedure that requires removal of endotracheal or tracheostomy tube
- Plan for prone or Trendelenburg (head down) positioning during most of the procedure
- 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)
- Plan for postoperative extubation in the procedure area
- 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
- Refusal to enroll patient by treating physician
- 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.
- Chronic mechanical ventilation at pre-admission level of care
Where
- Palo Alto, California
- San Francisco, California
- Aurora, Colorado
- Miami, Florida
- Chicago, Illinois
- Baltimore, Maryland
- Boston, Massachusetts
- Worcester, Massachusetts
- Minneapolis, Minnesota
- New York, New York
- Rochester, New York
- The Bronx, New York
And 4 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 12, 2026 · Source of record for eligibility and locations