Clinical trial NCT05906472: PUSH-IT Continuing Enteral Feeds for Tracheostomy
Official title: Prevent Unnecessary Surgeon Holds of Ingestions for Tracheostomy (PUSH-IT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tracheostomy Complication
Critical Illness
Nutritional Deficiency
Keywords: tube feed
nil per os
aspiration
pneumonia
nutritional delivery
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of aspiration pneumonia
timeFrame: Over 7 days from the time of tracheostomy
Secondary outcomes:
measure: Volume of tube feed delivery
timeFrame: From day of consent to completion of study which is 7 days from the time of tracheostomy.
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: St. Mary's Medical Center
state: Florida
city: Kansas City
country: United States
facility: HCA Research Medical Center
state: Missouri
city: Buffalo
country: United States
facility: Erie County Medical Center (University at Buffalo)
state: New York
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Columbia
country: United States
facility: University of South Carolina Sch of Medicine /Prisma Health Richland
state: South Carolina
Study officials:
affiliation: University at Buffalo
name: Marcy Jordan, PhD
role: STUDY_DIRECTOR
References: