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โ† Trials
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Preoperative Fasting vs. Not Fasting in Critically Ill Patients

RecruitingNAAges 18 Years - anyAllMassachusetts General Hospital
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In plain words

What the trial is, and whether it could suit you

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 o

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. 1\. Age โ‰ฅ 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) โ€ 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
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What it tests

  • Fasting
  • Not fasting
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Where

19 sites
Stanford Medical Center
Palo Alto, United States
UCSF Medical Center Parnassus
San Francisco, United States
University of Colorado Medical Center
Aurora, United States
University of Miami Hospital
Miami, United States
McGaw Medical Center of Northwestern
Chicago, United States
Rush University Medical Center
Chicago, United States
University of Maryland Medical Center
Baltimore, United States
Mass General Hospital
Boston, United States

โ€ฆand 11 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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