Recruiting

Enteral Feeds

Sponsor:

State University of New York at Buffalo

Code:

NCT05906472

Conditions

Tracheostomy Complication

Critical Illness

Nutritional Deficiency

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Feeds continued

Feeds held

Study Details

Brief summary:

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.

Conditions

Tracheostomy Complication

Critical Illness

Nutritional Deficiency

Study ID

NCT05906472

Start date

Feb 6, 2023

Status verified date

Oct, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Feeds continued

Enteral feeds are continued up until time of surgery

Feeds held

Enteral feeds are stopped 6 or more hours before surgery

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Eden Nohra, MD

3144439727edennohra@gmail.com

Locations

Nuvance Health - Danbury Hospital

Recruiting

Danbury, Connecticut, United States, 06810

Contacts

Catherine Badia

203-739-7643catherine.badia@nuvancehealth.org

Principal Investigator:

Krishan Patel, MD

St. Mary's Medical Center

Recruiting

West Palm Beach, Florida, United States, 33407

Contacts

Tracy Rodriguez

Tracy.Rodriguez@tenethealth.com

Principal Investigator:

Faris Azar, MD

HCA Research Medical Center

Recruiting

Kansas City, Missouri, United States, 64132

Contacts

John Chipko

John.Chipko@extanthealthcare.com

Principal Investigator:

Mark Leiser, MD

Erie County Medical Center (University at Buffalo)

Recruiting

Buffalo, New York, United States, 14215

Contacts

Michael Chopko, MD

716-898-5283mschopko@buffalo.edu

Marcy Jordan, PhD

716-898-5312marcyjor@buffalo.edu

Lehigh Valley Health Network

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Michael Farrell, MD

Michael.Farrell@lvhn.org

Principal Investigator:

Michael Farrell, MD

University of South Carolina Sch of Medicine /Prisma Health Richland

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Laura Reparaz

Laura.Reparaz@prismahealth.org

Principal Investigator:

James Conner, DO

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Keywords

  • tube feed
  • nil per os
  • aspiration
  • pneumonia
  • nutritional delivery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2025-10-20.