Tracheostomy ComplicationNCT05906472
PUSH-IT Continuing Enteral Feeds for Tracheostomy
A study testing Feeds continued and Feeds held in people with Tracheostomy Complication and Critical Illness, run by State University of New York at Buffalo at 6 sites in United States.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy Complication, Critical Illness, Nutritional Deficiency
- What is being tested?
- Feeds continued and Feeds held
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesUnited States
- Study dates
- 6 Feb 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- admitted to the intensive care unit (ICU)
- intubated and require tracheostomy
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Michael Farrell, MD, Michael.Farrell@lvhn.org
Michael Farrell, MD
- Recruiting
Erie County Medical Center (University at Buffalo)
Buffalo, New York, 14215
Michael Chopko, MD, 716-898-5283, mschopko@buffalo.edu
Marcy Jordan, PhD, 716-898-5312, marcyjor@buffalo.edu
- Recruiting
University of South Carolina Sch of Medicine /Prisma Health Richland
Columbia, South Carolina, 29203
Laura Reparaz, Laura.Reparaz@prismahealth.org
James Conner, DO
- Recruiting
Nuvance Health - Danbury Hospital
Danbury, Connecticut, 06810
Catherine Badia, 203-739-7643, catherine.badia@nuvancehealth.org
Krishan Patel, MD
- Recruiting
HCA Research Medical Center
Kansas City, Missouri, 64132
John Chipko, John.Chipko@extanthealthcare.com
Mark Leiser, MD
- Recruiting
St. Mary's Medical Center
West Palm Beach, Florida, 33407
Tracy Rodriguez, Tracy.Rodriguez@tenethealth.com
Faris Azar, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Feeds continued, Feeds held
- Keywords
- tube feed, nil per os, aspiration, pneumonia, nutritional delivery
- Medical subject headings
- Critical Illness, Malnutrition, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeds continuedOther
Enteral feeds are continued up until time of surgery
Feeds heldOther
Enteral feeds are stopped 6 or more hours before surgery
| Study group | Role | What they receive |
|---|---|---|
| Feeds continued | Experimental | Enteral feeds are continued up until time of tracheostomy. Receives: Other: Feeds continued |
| Feeds withheld | Other | Enteral feeds are withheld at least 6 hours prior to time of tracheostomy. Receives: Other: Feeds held |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Over 7 days from the time of tracheostomy
Secondary outcomes (1)
Volume of tube feed delivery
We will compare the volume of tube feeds delivered daily between the two groups for the duration of the study.
Measured: From day of consent to completion of study which is 7 days from the time of tracheostomy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start6 Feb 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheostomy ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eden Nohra, State University of New York at Buffalo
- Investigators
- Marcy Jordan, PhD, Study director, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906472
- Sponsor's protocol ID
- STUDY 00005099
- Status last verified
- Oct 2025
- First submitted
- 4 Jun 2023
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevent Unnecessary Surgeon Holds of Ingestions for Tracheostomy (PUSH-IT)
- ClinicalTrials.gov ID
- NCT05906472
- Acronym / sponsor ID
- STUDY 00005099
- Keywords
- tube feed, nil per os, aspiration, pneumonia, nutritional delivery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feeds continued | Experimental | Other: Feeds continuedEnteral feeds are continued up until time of tracheostomy. |
| Feeds withheld | Other | Other: Feeds heldEnteral feeds are withheld at least 6 hours prior to time of tracheostomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- admitted to the intensive care unit (ICU)
- intubated and require tracheostomy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feeds continuedEnteral feeds are continued up until time of surgery | Other | Feeds continued |
| Feeds heldEnteral feeds are stopped 6 or more hours before surgery | Other | Feeds withheld |
Primary outcome
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.
1 secondary outcome
Volume of tube feed delivery
Time frame: From day of consent to completion of study which is 7 days from the time of tracheostomy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcy Jordan, PhD study director
University at Buffalo
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeds continued and Feeds held in people with Tracheostomy Complication and Critical Illness, run by State University of New York at Buffalo at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eden Nohra, MD (3144439727, edennohra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of aspiration pneumonia (time frame: Over 7 days from the time of tracheostomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.