NCT05906472

PUSH-IT Continuing Enteral Feeds for Tracheostomy

Prevent Unnecessary Surgeon Holds of Ingestions for Tracheostomy (PUSH-IT)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Tracheostomy Complication
• Critical Illness
• Nutritional Deficiency

Interventions

Type	Name	Description
OTHER	Feeds continued	Enteral feeds are continued up until time of surgery
OTHER	Feeds held	Enteral feeds are stopped 6 or more hours before surgery

Timeline

• Start date: 2023-02-06
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-06-18
• Last updated: 2025-10-20

Locations

6 sites across 1 country: United States