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Simple tube tweak could save ICU patients from painful mouth sores

NCT ID NCT07390162

Prevention Sponsor: Hacettepe University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether repositioning a breathing tube every 4 hours versus every 8 hours can prevent mouth injuries in ICU patients. 230 adults on ventilators will be randomly assigned to one of the two schedules and monitored for 14 days. The goal is to find a clear time guideline that nurses can follow to reduce pressure sores in the mouth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
endotracheal tube repositioning (every 4 or 8 hours)
What this could lead to
If it works, this could establish a simple, low-cost routine to prevent painful mouth injuries in ICU patients on breathing tubes.
What could go wrong
This is a small, early-stage study (230 patients) testing only two time intervals. It may not find a clear difference, and results may not apply to all ICU settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

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

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

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: * The study will include patients over the age of 18, receiving MV support with oral ETT, with no tissue loss/damage in the oral mucosa at the time of admission to the ICU, who have been intubated for less than 24 hours, with an APACHE II score ≤24, and whose first-degree relatives or legal presentative have given consent for their participation in the study.

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Conditions

The condition(s) this trial relates to.

injury

As listed by the trial registrant

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

Adult patients Endotracheal intubation fixation Endotracheal tube position Intensive care units (ICUS) Mucosal erosion Mucosal irritation Mucosal wound Pressure ulcer prevention Repositioning

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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Other studies related to the condition(s) this trial covers.