RecruitingCritical IllnessSurgical Procedure, UnspecifiedPulmonary Aspiration

Preoperative Fasting vs. Not Fasting in Critically Ill Patients

Eligible age

18+ yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

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About this study

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. '

Sponsor: Massachusetts General Hospital

You may qualify if…

✓ 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

You may not qualify if…

✕ 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