PUSH-IT Continuing Enteral Feeds for Tracheostomy

Part of paid clinical trials in Danbury, Connecticut.

Sponsor
State University of New York at Buffalo
Study ID
NCT05906472
Status
Recruiting
Apply to this trial

Conditions

  • Critical Illness
  • Nutritional Deficiency
  • Tracheostomy Complication

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Feeds continued — OTHER
    Enteral feeds are continued up until time of surgery
  • Feeds held — OTHER
    Enteral feeds are stopped 6 or more hours before surgery

Study Details

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.

Key Dates

Start date
Feb 6, 2023
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Feeds continued
    Enteral feeds are continued up until time of tracheostomy.
  • Other: Feeds withheld
    Enteral feeds are withheld at least 6 hours prior to time of tracheostomy.

Primary Outcome Measure

Rate of aspiration pneumonia [ Time Frame: Over 7 days from the time of tracheostomy ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Nuvance Health - Danbury HospitalDanburyConnecticut06810
Catherine Badia
[email protected]
203-739-7643
Krishan Patel, MD (PRINCIPAL_INVESTIGATOR)
St. Mary's Medical CenterWest Palm BeachFlorida33407
Tracy Rodriguez
[email protected]
Faris Azar, MD (PRINCIPAL_INVESTIGATOR)
HCA Research Medical CenterKansas CityMissouri64132
Mark Leiser, MD (PRINCIPAL_INVESTIGATOR)
John Chipko, MD (SUB_INVESTIGATOR)
Erie County Medical Center (University at Buffalo)BuffaloNew York14215
Michael Chopko, MD
[email protected]
716-898-5283
Marcy Jordan, PhD
[email protected]
716-898-5312
Lehigh Valley Health NetworkAllentownPennsylvania18103
Michael Farrell, MD
[email protected]
Michael Farrell, MD (PRINCIPAL_INVESTIGATOR)
University of South Carolina Sch of Medicine /Prisma Health RichlandColumbiaSouth Carolina29203
Laura Reparaz
[email protected]
James Conner, DO (PRINCIPAL_INVESTIGATOR)

Find similar trials in Danbury, CT

By research site
Nuvance Health - Danbury Hospital· Danbury, CTSt. Mary's Medical Center· West Palm Beach, FLHCA Research Medical Center· Kansas City, MOErie County Medical Center (University at Buffalo)· Buffalo, NYLehigh Valley Health Network· Allentown, PAUniversity of South Carolina Sch of Medicine /Prisma Health Richland· Columbia, SC

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