PUSH-IT Continuing Enteral Feeds for Tracheostomy

Last updated: October 24, 2024
Sponsor: State University of New York at Buffalo
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diet And Nutrition

Weight Loss

Treatment

Feeds held

Feeds continued

Clinical Study ID

NCT05906472
STUDY 00005099
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to evaluate nutrition administration in the time around the tracheostomy in patients with breathing tubes. The main questions it aims to answer are:

  • Will continuing nutrition up to the time of surgery (tracheostomy) decrease nutrition interruptions, thereby increasing food intake?

  • Does continuing nutrition up to the time of surgery increase instances of food going into the lungs or lung infections?

Researchers will compare patients who have nutrition withheld 6 hours prior to surgery versus those who receive nutrition up until the time of surgery to see if there are differences in food intake, instances of food entering the lungs or lung infections.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years or older

  • admitted to the intensive care unit (ICU)

  • intubated and require tracheostomy

Exclusion

Exclusion Criteria:

  • under 18 years

  • unable to obtain informed consent

  • deemed clinically brain dead within 7 days of enrollment

  • transitioned to comfort measures within 7 days of enrollment

  • Pregnant patients

  • Prisoners

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Feeds held
Phase:
Study Start date:
February 06, 2023
Estimated Completion Date:
December 31, 2026

Study Description

Malnutrition is a significant problem in the critically ill, however with busy operating room schedules, we often find that feeds are interrupted repetitively prior to elective surgery. These interruptions are practiced based on the American Society of Anesthesiologist guidelines for fasting intervals for elective surgery. These guidelines, however, were not created for critically ill, intubated patients. The theoretical concern for an increased risk of aspiration with continuation of enteral feeds up to the time of surgery persists without supporting evidence. Thus, there is a need for a universal evidence-based guideline on perioperative enteral feeding to benefit critical care patients.

To this end, the goal of the present study is to implement a protocol designed to decrease the interruption of enteral feeds in critical care patients undergoing tracheostomy and prospectively evaluate whether this leads to a quantitative increase in nutritional intake without increasing the risk of aspiration. Additionally, we hope that increasing quantitative nutrition may decrease morbidity especially in the small subset of patients where feed interruptions occur repetitively.

If the aims of the project are achieved, the data obtained from this study will be used to create an evidence-based platform from which physicians can practice. This will end the anecdotal controversy regarding perioperative tube feed management for tracheostomy; thereby increasing quantitative nutrition and hopefully improving the care of critically ill patients.

Connect with a study center

  • St. Mary's Medical Center

    West Palm Beach, Florida 33407
    United States

    Active - Recruiting

  • HCA Research Medical Center

    Kansas City, Missouri 64132
    United States

    Active - Recruiting

  • Erie County Medical Center (University at Buffalo)

    Buffalo, New York 14215
    United States

    Active - Recruiting

  • Lehigh Valley Health Network

    Allentown, Pennsylvania 18103
    United States

    Active - Recruiting

  • University of South Carolina Sch of Medicine /Prisma Health Richland

    Columbia, South Carolina 29203
    United States

    Site Not Available

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