PUSH-IT Continuing Enteral Feeds for Tracheostomy

NCT05906472 | Recruiting DMC

• 1 other identifier: STUDY 00005099
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of aspiration pneumonia

  To assess differences in rates of aspiration events, a log-rank test for differences in survival curves model will be used. Assuming proportional hazards and non-informative censoring, a cox-model will be used to estimate follow-up hazard ratios for development of aspiration pneumonia between the two groups of interest.

  Over 7 days from the time of tracheostomy

Secondary Outcomes (1)

• Volume of tube feed delivery

  From day of consent to completion of study which is 7 days from the time of tracheostomy.

Study Arms (2)

Feeds continued

EXPERIMENTAL

Enteral feeds are continued up until time of tracheostomy.

Other: Feeds continued

Feeds withheld

OTHER

Enteral feeds are withheld at least 6 hours prior to time of tracheostomy.

Other: Feeds held

Interventions

Feeds continued OTHER

Enteral feeds are continued up until time of surgery

Feeds continued

Feeds held OTHER

Enteral feeds are stopped 6 or more hours before surgery

Feeds withheld

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• admitted to the intensive care unit (ICU)
• intubated and require tracheostomy

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (6)

Nuvance Health - Danbury Hospital

Danbury, Connecticut, 06810, United States

RECRUITING

St. Mary's Medical Center

West Palm Beach, Florida, 33407, United States

RECRUITING

HCA Research Medical Center

Kansas City, Missouri, 64132, United States

RECRUITING

Erie County Medical Center (University at Buffalo)

Buffalo, New York, 14215, United States

RECRUITING

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

RECRUITING

University of South Carolina Sch of Medicine /Prisma Health Richland

Columbia, South Carolina, 29203, United States

RECRUITING

MeSH Terms

Conditions

Critical Illness; Malnutrition; Pneumonia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Marcy Jordan, PhD

  University at Buffalo

  STUDY DIRECTOR

Central Study Contacts

Eden Nohra, MD

CONTACT

3144439727; edennohra@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 18, 2023
• Study Start: February 6, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (6)