PUSH-IT Continuing Enteral Feeds for Tracheostomy

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05906472
• Other study ID #: STUDY 00005099
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: State University of New York at Buffalo
• Contact: Eden Nohra, MD
• Phone: 3144439727
• Email: edennohra[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• admitted to the 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

Related Conditions & MeSH terms

• Critical Illness
• Malnutrition
• Nutritional Deficiency
• Tracheostomy Complication

Intervention

Other:
• Feeds continued
Enteral feeds are continued up until time of surgery
• Feeds held
Enteral feeds are stopped 6 or more hours before surgery

Locations

Country	Name	City	State
United States	Erie County Medical Center (University at Buffalo)	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of aspiration pneumonia	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.	Over 7 days from the time of tracheostomy
Secondary	Volume of tube feed delivery	We will compare the volume of tube feeds delivered daily between the two groups for the duration of the study.	From day of consent to completion of study which is 7 days from the time of tracheostomy.