PUSH-IT Continuing Enteral Feeds for Tracheostomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorState University of New York at Buffalo
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Feeds continued
Other interventionEnteral feeds are continued up until time of surgery
Feeds held
Other interventionEnteral feeds are stopped 6 or more hours before surgery
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Feeds continuedExperimental treatment 1 intervention
Group B: Feeds withheldOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Over 7 days from the time of tracheostomySecondary outcomes
1
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.
Time frame
From day of consent to completion of study which is 7 days from the time of tracheostomy.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov