About this trial

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.

Eligibility criteria

Qualifiers

18 years or older

admitted to the intensive care unit (ICU)

intubated and require tracheostomy

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Feeds continued
  • Feeds held

Treatment groups

200 Participants
are divided into 2 treatment groups

Locations

6
Connecticut
Nuvance Health - Danbury Hospital06810, Danbury United States
Florida
St. Mary's Medical Center33407, West Palm Beach United States
Missouri
HCA Research Medical Center64132, Kansas City United States
New York
Erie County Medical Center (University at Buffalo)14215, Buffalo United States

Sponsors and collaborators

State University of New York at Buffalo

Lead sponsor