RECRUITING

Preoperative Fasting vs. Not Fasting in Critically Ill Patients

Talk to us

Conditions

Critical IllnessSurgical Procedure, UnspecifiedPulmonary AspirationFastingenteral nutritiontube feedingpreoperative fastingperioperative medicinesurgery in critically illprocedures in critically illnutrition in critical illnessperioperative safetypreoperative managementpreoperative fasting in secure airwayanesthesia in critically ill

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. * 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. '

Official Title

FEEDS Trial - Fasting Preprocedurally in Enteral Nutrition: Evaluation of Divergent Approaches in Secure Airway

Quick Facts

Study Start:2025-04-28
Study Completion:2028-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06751043

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 18
  2. 2. Current admission to ICU
  3. 3. Secure airway with no plans for its removal prior to procedure
  4. 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. 5. Planned eligible procedure with anesthesia care or nursing sedation. Eligible procedures are defined as non-emergent diagnostic or therapeutic interventions that:
  6. * 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.)
  7. * Are NOT performed on the gastrointestinal tract or lung/airway.
  8. * Do NOT require prone or Trendelenburg (head-down) positioning.
  9. * Typically require procedural sedation or anesthesia care.
  10. * Generally, are scheduled for a specific time (although this time can change, or procedure may be cancelled).
  11. * Are performed in the operating room, non-operating room procedural areas, or at the patient's bedside.
  1. 1. Inability to obtain informed consent
  2. 2. Inability to enroll and randomize \> 8 hours prior to planned procedure time
  3. 3. Inability to deliver trial interventions
  4. 4. Expected survival \< 48 hours as determined by the enrolling physician-investigator
  5. 5. Critically ill burn patient
  6. 6. Emergency procedure
  7. 7. Gastrointestinal tract or airway/lung procedure
  8. 8. Plan for prone or Trendelenburg (head down) positioning during the procedure
  9. 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. 10. Plan for postoperative extubation in the procedure area
  11. 11. Prisoner
  12. 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

Contacts and Locations

Study Contact

Alexander Nagrebetsky, MD, MSC
CONTACT
617-724-3292
anagrebetsky@mgh.harvard.edu

Principal Investigator

Alexander Nagrebetsky, MD, MSC
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Mass General Hospital
Boston, Massachusetts, 02114
United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Alexander Nagrebetsky, MD, MSC, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-28
Study Completion Date2028-05

Study Record Updates

Study Start Date2025-04-28
Study Completion Date2028-05

Terms related to this study

Keywords Provided by Researchers

  • pulmonary aspiration
  • enteral nutrition
  • tube feeding
  • preoperative fasting
  • perioperative medicine
  • surgery in critically ill
  • procedures in critically ill
  • nutrition in critical illness
  • perioperative safety
  • preoperative management
  • preoperative fasting in secure airway
  • anesthesia in critically ill

Additional Relevant MeSH Terms

  • Critical Illness
  • Surgical Procedure, Unspecified
  • Pulmonary Aspiration
  • Fasting