PUSH-IT Continuing Enteral Feeds for Tracheostomy

October 16, 2025 updated by: Eden Nohra, State University of New York at Buffalo

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Malnutrition is a significant problem in the critically ill, however with busy operating room schedules, we often find that feeds are interrupted repetitively prior to elective surgery. These interruptions are practiced based on the American Society of Anesthesiologist guidelines for fasting intervals for elective surgery. These guidelines, however, were not created for critically ill, intubated patients. The theoretical concern for an increased risk of aspiration with continuation of enteral feeds up to the time of surgery persists without supporting evidence. Thus, there is a need for a universal evidence-based guideline on perioperative enteral feeding to benefit critical care patients.

To this end, the goal of the present study is to implement a protocol designed to decrease the interruption of enteral feeds in critical care patients undergoing tracheostomy and prospectively evaluate whether this leads to a quantitative increase in nutritional intake without increasing the risk of aspiration. Additionally, we hope that increasing quantitative nutrition may decrease morbidity especially in the small subset of patients where feed interruptions occur repetitively.

If the aims of the project are achieved, the data obtained from this study will be used to create an evidence-based platform from which physicians can practice. This will end the anecdotal controversy regarding perioperative tube feed management for tracheostomy; thereby increasing quantitative nutrition and hopefully improving the care of critically ill patients.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Recruiting
        • Nuvance Health - Danbury Hospital
        • Contact:
        • Principal Investigator:
          • Krishan Patel, MD
    • Florida
      • West Palm Beach, Florida, United States, 33407
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Recruiting
        • HCA Research Medical Center
        • Principal Investigator:
          • Mark Leiser, MD
        • Contact:
        • Sub-Investigator:
          • John Chipko, MD
    • New York
      • Buffalo, New York, United States, 14215
        • Recruiting
        • Erie County Medical Center (University at Buffalo)
        • Contact:
        • Contact:
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Health Network
        • Contact:
        • Principal Investigator:
          • Michael Farrell, MD
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Recruiting
        • University of South Carolina Sch of Medicine /Prisma Health Richland
        • Contact:
        • Principal Investigator:
          • James Conner, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Feeds continued
Enteral feeds are continued up until time of tracheostomy.
Other: Feeds continued
Enteral feeds are continued up until time of surgery
Other: Feeds withheld
Enteral feeds are withheld at least 6 hours prior to time of tracheostomy.
Other: Feeds held
Enteral feeds are stopped 6 or more hours before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of aspiration pneumonia
Time Frame: Over 7 days from the time of tracheostomy
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of tube feed delivery
Time Frame: From day of consent to completion of study which is 7 days from the time of tracheostomy.
We will compare the volume of tube feeds delivered daily between the two groups for the duration of the study.
From day of consent to completion of study which is 7 days from the time of tracheostomy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Investigators

  • Study Director: Marcy Jordan, PhD, University at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 4, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Estimated)

October 20, 2025

Last Update Submitted That Met QC Criteria

October 16, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY 00005099

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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