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ICU feeding study challenges fasting rules before tracheostomy

NCT ID NCT07508293

Knowledge-focused Sponsor: Bursa Yuksek Ihtisas Training and Research Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study observed 91 ICU patients on breathing machines who needed a tracheostomy (a tube in the windpipe). One group continued receiving liquid food through a feeding tube until just before the procedure, while the other group fasted for 6-8 hours as usual. Researchers tracked whether continuing feeding increased the risk of aspiration pneumonia (lung infection from food or liquid entering the airway) within 72 hours after the procedure. The goal was to see if skipping the fasting period is safe and helps maintain nutrition in critically ill patients.

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Study facts

What this study's own registry entry says, in plain language.

Participants

91 people

The number who actually took part.

Started

Dec 2022

Finished

Jan 2024

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of adult (≥18 years) mechanically ventilated patients admitted to the intensive care units of Bursa Yüksek İhtisas Training and Research Hospital who were scheduled for elective bedside percutaneous tracheostomy. Patients were managed according to routine ICU enteral nutrition practices and included those receiving either continuous enteral feeding until tracheostomy preparation or conventional pre-procedural fasting.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18 years 2. Mechanically ventilated patients in the intensive care unit 3. Receiving enteral nutrition 4. Scheduled for elective percutaneous tracheostomy 5. No radiologically confirmed active pneumonia at baseline 6. No diagnosis of acute respiratory distress syndrome (ARDS) 7. No ventilator-associated pneumonia at the time of tracheostomy * Exclusion Criteria: 1-) Early death after ICU admission 2-) Inability to receive enteral nutrition (e.g., ileostomy, colostomy, severe gastrointestinal pathology) 3-) Clinically significant gastric intolerance (persistent vomiting, abdominal distension, feeding intolerance) 4-) Hemodynamic instability requiring inotropic support 5-) Refusal of participation by patient or legal representative 6-) Pre-procedural enteral nutrition interruption between 1-6 hours 7-) Missing or incomplete clinical data

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Conditions

The condition(s) this trial relates to.

aspiration pneumonia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aspiration pneumonia Mechanical ventilation Tracheostomy

Contacts and locations

Locations

  • Mimarsinan Mah. Emniyet Cad. 16310 Yıldırım/Bursa

    Bursa, Bursa, 16310, Turkey (Türkiye)

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