PUSH-IT Continuing Enteral Feeds for Tracheostomy

Not Applicable

Recruiting

• Conditions: Tracheostomy Complication; Critical Illness; Nutritional Deficiency
• Interventions: Other: Feeds held; Other: Feeds continued

• Registration Number: NCT05906472
• Lead Sponsor: State University of New York at Buffalo

Brief 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.

Study Timeline

• Study Start: 2023-02-06
• Study First Submitted: 2023-06-04
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-26
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 18 years or older
• admitted to the intensive care unit (ICU)
• intubated and require tracheostomy

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Feeds withheld	Feeds held	Enteral feeds are withheld at least 6 hours prior to time of tracheostomy.
Feeds continued	Feeds continued	Enteral feeds are continued up until time of tracheostomy.

Primary Outcome Measures

Name	Time	Method
Rate of aspiration pneumonia	Over 7 days from the time of tracheostomy	To assess differences in rates of aspiration events, a log-rank test for differences in survival curves model will be used. Assuming proportional hazards and non-informative censoring, a cox-model will be used to estimate follow-up hazard ratios for development of aspiration pneumonia between the two groups of interest.

Secondary Outcome Measures

Name	Time	Method
Volume of tube feed delivery	From day of consent to completion of study which is 7 days from the time of tracheostomy.	We will compare the volume of tube feeds delivered daily between the two groups for the duration of the study.

Trial Locations

Locations (5)

University of South Carolina Sch of Medicine /Prisma Health Richland; 🇺🇸 Columbia, South Carolina, United States

St. Mary's Medical Center; 🇺🇸 West Palm Beach, Florida, United States

HCA Research Medical Center; 🇺🇸 Kansas City, Missouri, United States

Lehigh Valley Health Network; 🇺🇸 Allentown, Pennsylvania, United States

Erie County Medical Center (University at Buffalo); 🇺🇸 Buffalo, New York, United States