Continuing nutrition during tracheostomy surgery
Prevent Unnecessary Surgeon Holds of Ingestions for Tracheostomy (PUSH-IT)
NA · State University of New York at Buffalo · NCT05906472
This study tests if keeping critically ill patients on nutrition right up until their tracheostomy surgery helps them eat better afterward without increasing the risk of lung problems.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | State University of New York at Buffalo (other) |
| Locations | 6 sites (Danbury, Connecticut and 5 other locations) |
| Trial ID | NCT05906472 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of continuing enteral nutrition up to the time of tracheostomy surgery in critically ill patients. It compares two groups: one that has nutrition withheld for 6 hours prior to surgery and another that continues receiving nutrition until surgery. The study aims to determine if uninterrupted nutrition leads to increased food intake without raising the risk of aspiration or lung infections. The findings could help establish evidence-based guidelines for managing nutrition in critically ill patients undergoing tracheostomy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are intubated and require tracheostomy while admitted to the ICU.
Not a fit: Patients under 18, those unable to provide informed consent, or those transitioning to comfort measures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve nutritional intake and reduce complications in critically ill patients undergoing tracheostomy.
How similar studies have performed: While there is limited evidence on this specific approach, the need for improved nutritional management in critically ill patients suggests potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * admitted to the intensive care unit (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
Where this trial is running
Danbury, Connecticut and 5 other locations
- Nuvance Health - Danbury Hospital — Danbury, Connecticut, United States (RECRUITING)
- St. Mary's Medical Center — West Palm Beach, Florida, United States (RECRUITING)
- HCA Research Medical Center — Kansas City, Missouri, United States (RECRUITING)
- Erie County Medical Center (University at Buffalo) — Buffalo, New York, United States (RECRUITING)
- Lehigh Valley Health Network — Allentown, Pennsylvania, United States (RECRUITING)
- University of South Carolina Sch of Medicine /Prisma Health Richland — Columbia, South Carolina, United States (RECRUITING)
Study contacts
- Study coordinator: Eden Nohra, MD
- Email: edennohra@gmail.com
- Phone: 3144439727
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tracheostomy Complication, Critical Illness, Nutritional Deficiency, tube feed, nil per os, aspiration, pneumonia, nutritional delivery