Preoperative Fasting vs. Not Fasting in Critically Ill Patients

Launched by MASSACHUSETTS GENERAL HOSPITAL · Dec 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to find out whether fasting or not fasting before a medical procedure affects recovery for critically ill patients who are on a breathing machine and receiving nutrition through a tube. The study aims to answer important questions about the risks of lung problems and death, how long it takes to recover, and whether there are differences in infections, hospital stays, and nutritional outcomes between those who fast and those who do not.

To participate, you must be at least 18 years old, currently in the Intensive Care Unit (ICU), and receiving tube feeding without plans to stop it before the procedure. If you join the study, you will be randomly assigned to either the fasting group, where tube feeding will be stopped at least 8 hours before the procedure, or the not fasting group, where it will stop right before the procedure. You’ll be monitored for any complications and will receive a follow-up call about three months later to check on your recovery. This trial is important because it could help improve care for patients undergoing procedures while critically ill.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 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.)
• • Are NOT performed on the gastrointestinal tract or lung/airway.
• • 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.
• 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. Gastrointestinal tract or airway/lung procedure
• • 8. Plan for prone or Trendelenburg (head down) positioning during 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