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.
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.
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.
- Conditions
- Mucosal Wound, Mucosal Erosion, Mucosal Irritation, Endotracheal Intubation Fixation, Endotracheal Tube Position, Repositioning
- 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 group | Role | What they receive |
|---|---|---|
| APACHE II score ≤20 Patients | Experimental | Not described Receives: Other: Changes in the frequency of endotracheal tube repositioning |
| APACHE II score 20-24 Patients | Experimental | Not 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.
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.
- First posted5 Feb 2026
- Study start30 Jun 2026 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mucosal WoundStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ecem Ozdemir, Hacettepe University
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 40068960Ozdemir 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Changes in the Frequency of Endotracheal Tube Repositioning in Intensive Care Units on the Prevention of Oral Mucosal Pressure Injuries
- ClinicalTrials.gov ID
- NCT07390162
- Acronym / sponsor ID
- PreventionMMPI / 2025/07-02 (KA-24086)-D-Number
- Conditions
- Mucosal Wound, Mucosal Erosion, Mucosal Irritation, Endotracheal Intubation Fixation, Endotracheal Tube Position, Repositioning
- Keywords
- mucosal membrane pressure injury, Intensive Care Units (ICUs), Endotracheal intubation fixation, Repositioning, pressure ulcer prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 5 Feb 2026 (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.
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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| APACHE II score ≤20 Patients | Experimental | Other: Changes in the frequency of endotracheal tube repositioning |
| APACHE II score 20-24 Patients | Experimental | Other: Changes in the frequency of endotracheal tube repositioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Changes in the frequency of endotracheal tube repositioningEnsuring changes in the frequency of endotracheal tube repositioning (two experimental groups of 4 and 8 hours) | Other | APACHE II score 20-24 Patients, APACHE II score ≤20 Patients |
Primary outcome
Oral mucosal pressure injury formation
Time frame: Throughout the entire 14-day follow-up period
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.
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 25 Jun 2026.
- Results publication: PubMed 40068960Ozdemir 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.
- Derived from this study: PubMed 42265981Ozdemir 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.
- Individual participant dataSharing planned: No. Since this is a planned doctoral thesis in the field of nursing, it should remain as it is for now.
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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.
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.