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Mucosal WoundPreventionMMPINCT07390162

The Effect of Changes in the Frequency of Endotracheal Tube Repositioning in Intensive Care Units on the Prevention of Oral Mucosal Pressure Injuries

A study testing Changes in the frequency of endotracheal tube repositioning in people with Mucosal Wound and Mucosal Erosion, run by Hacettepe University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Intensive care units (ICUs) are care centers equipped with a wide range of technological tools and devices used to provide the highest level of care to individuals whose lives are at risk, requiring a multidisciplinary team approach. Patients may require respiratory support from a ventilator to maintain breathing. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mucosal Wound, Mucosal Erosion, Mucosal Irritation
What is being tested?
Changes in the frequency of endotracheal tube repositioning
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
No sites listed yet
Study dates
30 Jun 2026to 15 Jun 2027
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

  • 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.

Who cannot join

None listed.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ecem Research Assistant contact

+905427306671

ecem96.eo@gmail.com

About this study

Intensive care units (ICUs) are care centers equipped with a wide range of technological tools and devices used to provide the highest level of care to individuals whose lives are at risk, requiring a multidisciplinary team approach. Patients may require respiratory support from a ventilator to maintain breathing. In the intensive care unit, patients' breathing is maintained using a medical device called an endotracheal tube (ETT). ETTs can cause injuries due to the constant pressure they exert on the patient's mouth and lip area. Therefore, nurses must secure the ETT at specific times to different points in the mouth area (right and left sides of the mouth) to prevent these injuries. Injuries to the mucosa caused by medical equipment are defined as "mucosal membrane pressure injuries (MMPI)." One such injury is an injury to the mouth. Injuries occurring in the mouth are caused by the pressure of the tubes that enable the patient to breathe in and out.

"The Effect of Changes in the Frequency of Endotracheal Tube Repositioning in Intensive Care Units on the Prevention of Oral Mucosal Pressure Injuries" is a doctoral thesis study; the aim of this study is to investigate the effect of differences in the time interval for changing the position of the tube in the lip region on the prevention of injuries occurring in the mouth in patients monitored with ETT in the ICU. A review of the literature revealed that there are gaps in studies conducted at the international or national level on this subject, and that there is no definitive time guideline for changing (repositioning) the tube in the lip area.

Read more

The study will include patients over the age of 18 who are being monitored with an ETT in their mouth, who did not have any injuries in the mouth area at the time of admission to the ICU, who have not had the tube in their mouth for more than 24 hours, who are in moderate to good general condition, and whose first-degree relatives or legal presentative have given permission for them to participate in the study. In the study, the follow-up and evaluation of patients will be limited to fourteen days after tube insertion. Exclusion Criteria; Differences in respiratory support, Pre-existing artificial airway, Oncological conditions, Neurological and behavioral factors, Positional constraints, Sensory/perceptual impairment, Pre-existing injury. Patients who are discharged or transferred during the fourteen-day follow-up period will be excluded from the study. According to the sample calculation for the study, a total of 230 patients (115 volunteers in the 4-hour group and 115 volunteers in the 8-hour group) will be sufficient. In the study, patients will be stratified according to their APACHE II scores. ICU nurses are not bound by any specific time for securing the ETT. Nurses positioned the tube fixation site at the right lip edge/left lip edge/mid-lip line; however, since they were not bound by a specific time-based rule, tube care was nurse-specific. In this study, the location of tube fixation will be recorded through observation to determine the effect of tube fixation on the formation of oral injuries. This study is planned to be completed within a 24-month timeframe between May 30, 2026, and June 15, 2027.

This research is a scientific research (doctoral thesis) study. The daily tube care of volunteers is already in place, and we emphasize that this research will not affect/interfere with the treatment and follow-up of volunteers, and that volunteers will not be negatively affected by the study in any way. The principal investigator will randomly assign volunteers being monitored with ETT to groups using a computer system and will request nurses to reposition their ETTs based on the time intervals (4 hours-8 hours) within these groups. At the same time, the researcher will collect relevant clinical data that may affect pressure injuries in patients (age, gender, smoking history, body mass index, medical history, ICU admission diagnosis, SOFA, RASS and APACHE II scores, Glasgow Coma Scale, laboratory findings (C-reactive protein, white blood cell, Hemoglobin, Hematocrit, Total Protein, Albumin, pH, PO2, Blood Sugar Level), Nutritional Status (Route and Type of Nutrition, Product), Medication Support (Sedatives, Inotropes, Antibiotics, Steroids), ETT-Related Data (Number, Depth, Fixation Site, Repositioning Time), Eilers Oral Assessment Guide and Oral Care Frequency, Braden Pressure Ulcer Risk Assessment Scale and Overall Body Pressure Ulcer Presence, Reaper Oral Mucosa Pressure Injury Scale Grade data, etc.). The follow-up period in the study will be fourteen days, during which the principal investigator will record the patients' personal health data mentioned above and terminate the follow-up of patients who develop pressure injuries in the oral mucosa. Our expectation from the study is that no injuries will occur in the mouth. In the event of a possible injury, the intervention will be terminated immediately.

Read the detailed description

In the study, the legal representative of the volunteer will be informed in such a case, and the routine tube repositioning schedule (twice a day, every 12 hours) of the intensive care unit will be resumed. The study is being conducted to shorten the frequency of tube repositioning and to prevent oral mucosal pressure injuries. In accordance with Law No. 6698 on the Protection of Personal Data, the volunteers' names, surnames, and Turkish ID numbers will not be collected. Only personal health data related to chronic diseases, age, and the aforementioned pressure injuries, as listed in the data collection form, will be collected by the responsible researcher. Even when the research is published, the volunteers' identity information will remain confidential. The data in the research will be accessible to the ethics committee, the institution, and other relevant health authorities, who will be able to directly access the volunteer's original medical records. However, this information will be kept confidential in accordance with Law No. 6698, and the legal representative will have given permission for such access by signing the written informed consent form. If new information related to the research topic is obtained that could affect the volunteer's desire to continue participating in the research, the legal representative will be informed in a timely manner. The records obtained will be kept by the researchers for a certain period of time and destroyed after 15 years. Participation in this study is entirely voluntary. Volunteers are currently patients receiving treatment in the intensive care unit and have no responsibility for the study. The legal representatives of volunteers are responsible for not disclosing information about the study to outsiders. You have the right to refuse to participate in the study or to withdraw from it at any time after participating. By filling in and signing the box below with your name, you indicate your consent to participate in the study. The information obtained from this study will be used solely for research purposes. You will not be paid for participating in the study.

I have read all the explanations in the Informed Consent Form. The researchers listed below have provided me with written and verbal explanations regarding the research described above. I understand that I am participating in the research voluntarily and that I may withdraw from the research at any time, with or without cause. I agree to participate in the research of my own free will, without any pressure or coercion.

Being tested
Changes in the frequency of endotracheal tube repositioning
Keywords
mucosal membrane pressure injury, Intensive Care Units (ICUs), Endotracheal intubation fixation, Repositioning, pressure ulcer prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Changes in the frequency of endotracheal tube repositioningOther

    Ensuring changes in the frequency of endotracheal tube repositioning (two experimental groups of 4 and 8 hours)

Study groups in NCT07390162
Study groupRoleWhat they receive
APACHE II score ≤20 PatientsExperimentalNot described
Receives: Other: Changes in the frequency of endotracheal tube repositioning
APACHE II score 20-24 PatientsExperimentalNot described
Receives: Other: Changes in the frequency of endotracheal tube repositioning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oral mucosal pressure injury formation

    The primary outcome will be the development of oral mucosal pressure injury, with all occurrences monitored and recorded over the 14-day period rather than at a single time point.

    Measured: Throughout the entire 14-day follow-up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2026
  2. Study start30 Jun 2026 (estimated)
  3. Primary completion15 Jul 2026 (estimated)
  4. Study completion15 Jun 2027 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomization in the study will be performed using Random Allocation Software 2.0, and patients will be randomized into two groups (4 hours and 8 hours) based on the duration of ETT repositioning. Inclusion Criteria: * Over 18 years of age, * Receiving MV support with an oral ETT, * No tissue loss/damage in the oral mucosa at the time of admission to the ICU, * Less than 24 hours since intubation, * APACHE II score ≤24, * Patients whose first-degree relatives or legal presentative have given consent for participation in the study will be included. Patients meeting any of the following criteria will not be included in the study: Exclusion Criteria * Differences in respiratory support * Pre-existing artificial airway * Oncological conditions * Neurological and behavioral factors * Positional constraints * Sensory/perceptual impairment * Pre-existing injury In the study, patients will be stratified according to their APACHE II scores (APACHE \<20---APACHE 20-24).
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07390162
Sponsor's protocol ID
2025/07-02 (KA-24086)-D-Number
Other IDs
2025/07-02 (KA-24086)-D-Number, Clinical Research Ethics C.
Acronym
PreventionMMPI
Status last verified
Jun 2026
First submitted
31 Jul 2025
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Since this is a planned doctoral thesis in the field of nursing, it should remain as it is for now.

Publications

  • Ozdemir E, Kavakli O. Risk factors for oral mucosal pressure injury associated with endotracheal tubes in intensive care unit patients: A single-centre longitudinal study with brief follow-up. Nurs Crit Care. 2025 Mar;30(2):e70009. doi: 10.1111/nicc.70009.

    PubMed 40068960
  • Ozdemir E, Korkmaz F, Dereli N. Endotracheal Tube Repositioning Frequency for Preventing Oral Mucosal Pressure Injuries in Intensive Care Units: A Randomised Controlled Trial Study Protocol. Nurs Crit Care. 2026 Jul;31(4):e70529. doi: 10.1111/nicc.70529.

    PubMed 42265981

Questions about this trial

What is this clinical trial studying?

A study testing Changes in the frequency of endotracheal tube repositioning in people with Mucosal Wound and Mucosal Erosion, run by Hacettepe University.

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 1 inclusion and 0 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: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Ecem Research Assistant (+905427306671, ecem96.eo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oral mucosal pressure injury formation (time frame: Throughout the entire 14-day follow-up period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07390162, which also lists 2 linked publications.

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 25 Jun 2026.

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