PUSH-IT Continuing Enteral Feeds for Tracheostomy

University at Buffalo (UB)

Status: Enrolling

Conditions: Tracheostomy Complication; Critical Illness; Nutritional Deficiency

Treatments: Other: Feeds held; Other: Feeds continued

Study type: Interventional

Funder types: Other

Identifiers

NCT05906472

STUDY 00005099

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Feeds continued

Experimental group

Description:

Enteral feeds are continued up until time of tracheostomy.

Treatment:

Other: Feeds continued

Feeds withheld

Other group

Description:

Enteral feeds are withheld at least 6 hours prior to time of tracheostomy.

Treatment:

Other: Feeds held