Push-It: Prevent Unnecessary Surgeon Holds of Ingestions for Tracheostomy

Studying Feeding Before Tracheostomy in ICU Patients

O
Owen McCabe

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
1 participants needed
1 Location

Brief description of study

To determine if continuation of enteral feeds up to the time of tracheostomy improves nutritional status as evident by total caloric intake, and has no effect on risk of aspiration as evident by reported feed material in mouth, worsening consolidation or opacification on chest x-ray within 48 hours, increased requirement of O2/ Positive End-Expiratory Pressure (PEEP), worsening ABG, and pneumonia within 7 days

THIS STUDY IS ENROLLING BY INVITATION ONLY - The study population will be adult patients admitted to surgical and trauma Intensive Care Units who require tracheostomy. Once admitted to the ICU, the study team will go through the study screening protocol. The investigator will be notified if a patient screens positive. Informed consent for enrollment into the study group will be sought. 

Detailed description of study

Primary Objectives:
To determine if continuation of enteral feeds up to the time of tracheostomy improves nutritional status as evident by total caloric intake, and has no effect on risk of aspiration as evident by reported feed material in mouth, worsening consolidation or opacification on chest x-ray within 48 hours, increased requirement of O2/ PEEP, worsening ABG, and pneumonia within 7 days.

Once a patient is screened and consent is obtained, these patients will then be randomized to our continued enteral feeds arm up to the time of surgery versus nil per os six hours prior.

If randomized to the continued enteral feed arm, the patients will continue to receive enteral feeds via their nasogastric or nasoduodenal tube which was placed at the discretion of the critical care physician. Our goal is to continue tube feeds up to the time of surgery at which time the feeding tube is put to suction to remove gastric contents at the discretion the treating anesthesiologist. 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Trachea, Tracheostomy
  • Age: 18 years - 100 years
  • Gender: All

Inclusion criteria:

  • Patients admitted to the ICU who are 18 years or older and intubated and require tracheostomy 

This study investigates the effects of continuing enteral feeding right up to the time of tracheostomy in patients in the Intensive Care Unit (ICU). A tracheostomy is a medical procedure where an opening is made in the neck to place a tube into a person's windpipe. This study aims to see if continuing feeding improves nutrition without increasing the risk of problems like food entering the lungs, which is called aspiration.

Participants will be divided into two study arms. One group will continue to receive their enteral feeds through a tube until the time of surgery. The other group will stop feeding six hours before surgery. Enteral feeding means providing food through a tube that goes to the stomach or small intestine. The study will monitor for any signs of aspiration, changes in chest x-rays, and other health indicators after the surgery.

  • Who can participate: Adults aged 18 and older who are in the ICU, intubated, and require a tracheostomy can participate.
  • Study details: Participants will be randomly assigned to either continue receiving enteral feeds until surgery or to stop feeds six hours before surgery. Enteral feeding involves using a tube to deliver food directly to the stomach or small intestine.
Updated on 12 May 2026. Study ID: SURG-UBUFFALO-PUSH-IT, 28360
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only