FEEDS Trial - Fasting Preprocedurally in Enteral Nutrition: Evaluation of Divergent Approaches in Secure Airway
Massachusetts General Hospital
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. * Receive a phone call from the study team about 3 months after they enter the study to see how they are doing and complete a questionnaire. '
Description
Patient Population: Critically ill patients in the ICU who are: mechanically ventilated, receiving tube feeding (enteral nutrition), with a planned surgery or procedure. Up to 1072 subjects will be enrolled. Phase III pragmatic multicenter parallel-group randomized controlled non-inferiority trial with patient-level randomization and assessor blinding. Enrollment Period: Approximately two years. Aims: * Aim 1: To compare the risk of pulmonary complications and mortality from: (1) perioperative pulmonary aspiration6,33,34 due to not fasting vs. (2) systemic effects of nutritional loss18-24…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- OtherFasting
Process: Fasting pre-procedure Tube feeding will be stopped at least 8 hours before the patient's scheduled surgery or procedure time.
- OtherNot fasting
Process: Not fasting pre-procedure Tube feeding will be continued until patient transfer to the operating room/procedure area.
Locations (19)
- Stanford Medical CenterPalo Alto, California
- UCSF Medical Center ParnassusSan Francisco, California
- University of Colorado Medical CenterAurora, Colorado
- University of Miami HospitalMiami, Florida
- McGaw Medical Center of NorthwesternChicago, Illinois
- Rush University Medical CenterChicago, Illinois