PUSH-IT Continuing Enteral Feeds for Tracheostomy
This study is looking at how nutrition is given to critically ill patients who need a tracheostomy (a breathing tube placed in the windpipe). Researchers want to see if continuing enteral feeds (nutrition given through a tube into the stomach or intestines) right up until surgery affects how much food patients receive and if it increases the risk of aspiration pneumonia (a lung infection caused by inhaling food or liquid). You may be able to join if you are 18 or older, in the intensive care unit (ICU), and need a tracheostomy. The study will compare patients who continue feeds until surgery with those whose feeds are stopped 6 or more hours before surgery. The main goal is to see if continuing feeds changes the rate of aspiration pneumonia within 7 days after the tracheostomy. The current status of this study is unclear.
- Study design
- This is an interventional study planning to enroll 200 participants. It compares two groups: one that continues enteral feeds until surgery and another that stops feeds 6 or more hours before surgery.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, aspiration pneumonia, is measured over 7 days from the time of tracheostomy.
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PUSH-IT Continuing Enteral Feeds for Tracheostomy
At a glance
Conditions
Where it's being run
6 sites across 6 statesStudy leadership
- Marcy Jordan, PhD · STUDY_DIRECTOR · University at Buffalo
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Rate of aspiration pneumoniaOver 7 days from the time of tracheostomy
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.