Actively Recruiting
Prevent Unnecessary Surgeon Holds of Ingestions for Tracheostomy (PUSH-IT) Continuing Enteral Feeds Around Tracheostomy Surgery
Led by State University of New York at Buffalo · Updated on 2025-10-20
200
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the timing of nutrition in critically ill patients undergoing tracheostomy surgery. This study aims to find out if continuing nutrition up to the time of surgery reduces interruptions in feeding and increases food intake without raising the risk of aspiration pneumonia or lung infections. The study addresses the lack of evidence for current fasting guidelines, which may not be suitable for intubated critical care patients. Participants will be randomly assigned to one of two groups: one group will continue receiving enteral feeding until the time of tracheostomy, while the other group will have enteral feeding withheld at least six hours before surgery. This comparison seeks to determine if uninterrupted feeding improves nutritional intake without increasing lung-related complications. During the study, researchers will monitor participants for seven days after the tracheostomy, assessing the rate of aspiration pneumonia as the main outcome. They will also measure the volume of tube feeding delivered from consent until the study ends. The study involves intensive care patients who are intubated and require tracheostomy, with careful tracking of nutrition delivery and lung health throughout the trial.
CONDITIONS
Brief Title
PUSH-IT Continuing Enteral Feeds for Tracheostomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Admitted to the intensive care unit (ICU)
- Intubated and require tracheostomy
You will not qualify if you...
- Under 18 years
- Unable to obtain informed consent
- Clinically brain dead within 7 days of enrollment
- Transitioned to comfort measures within 7 days of enrollment
- Pregnant patients
- Prisoners
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 7 days from the time of tracheostomy
Participants receive either continued enteral feeds up until the time of tracheostomy or have feeds withheld at least 6 hours prior to surgery to evaluate effects on nutritional intake and aspiration risk.
Daily assessments during the 7-day period after surgery
Trial Site Locations
Total: 6 locations
1
Nuvance Health - Danbury Hospital
Danbury, Connecticut, United States, 06810
Actively Recruiting
2
St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
Actively Recruiting
3
HCA Research Medical Center
Kansas City, Missouri, United States, 64132
Actively Recruiting
4
Erie County Medical Center (University at Buffalo)
Buffalo, New York, United States, 14215
Actively Recruiting
5
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
6
University of South Carolina Sch of Medicine /Prisma Health Richland
Columbia, South Carolina, United States, 29203
Actively Recruiting
Research Team
E
Eden Nohra, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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