Clinical trial Recruiting at 6 sites Interventional Ages 18 and up

Continuing nutrition during tracheostomy surgery

Official title: Prevent Unnecessary Surgeon Holds of Ingestions for Tracheostomy (PUSH-IT)

Run by State University of New York at Buffalo · NCT05906472 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorState University of New York at Buffalo
Academic / other
Locations6 sites (Danbury, Connecticut and 5 other locations)
StatusRecruiting
StartedFebruary 6, 2023
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedOctober 20, 2025
Trial IDNCT05906472 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older who are intubated and require tracheostomy while admitted to the ICU.

Probably not a fit

Patients under 18, those unable to provide informed consent, or those transitioning to comfort measures may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While there is limited evidence on this specific approach, the need for improved nutritional management in critically ill patients suggests potential for success.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.