Elderlymucosal injuryNCT07684443
Oral Mucosal Pressure Injuries and Endotracheal Tube Dislodgement Among Elderly Trauma Patients
A study testing AnchorFast : Endotracheal Tube Securement Device in people with Elderly and Trauma ICU Patients, run by Norther Private Collage of Nursing at 1 site in Saudi Arabia.
Trial summary
This randomized controlled trial aims to compare the effectiveness of the AnchorFast™ endotracheal tube (ETT) securement device with conventional adhesive tape and gauze fixation in preventing oral mucosal pressure injuries and endotracheal tube dislodgement among mechanically ventilated elderly trauma patients… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Elderly, Trauma ICU Patients
- What is being tested?
- AnchorFast : Endotracheal Tube Securement Device
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Dec 2025to 29 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥65 years old and more.
- Newly admission to trauma ICU following traumatic injury
- Patient attached with EET and mechanical ventilation
- Expected duration of mechanical ventilation for 72 hours and more.
- Hemodynamically stable (MAP ≥65 mmHg with or without vasopressors)
- Informed consent obtained from patient or legally authorized representative
- Enrollment within 6 hours of intubation
Who cannot join
- Extubation:
- Pre-existing tracheostomy and planned tracheostomy within 72 hours
- Patients with facial trauma or facial burns or active facial skin.
- Known allergy to adhesive materials or device components
- Active facial skin infection or significant dermatologic condition
- Enrollment in another interventional study
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- Do-not-resuscitate status or comfort care designation
- Expected survival less than 72 hours based on clinical judgment
- Oral surgery or oral infection or inflammation.
- A previous neck injury, projecting upper teeth, or the absence of teeth.
- Radiotherapy-induced oral mucositis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Mucosal Pressure Injuries and Endotracheal Tube Dislodgement: A Randomized Controlled Trial Comparing Securement Methods in Elderly Trauma Patients
This randomized controlled trial aims to compare the effectiveness of the AnchorFast™ endotracheal tube (ETT) securement device with conventional adhesive tape and gauze fixation in preventing oral mucosal pressure injuries and endotracheal tube dislodgement among mechanically ventilated elderly trauma patients admitted to the intensive care unit. A total of 90 patients aged 65 years and older requiring oral endotracheal intubation will be randomly allocated to one of the three securement methods. The primary outcomes are the incidence and severity of oral mucosal pressure injuries, assessed using the Beck Oral Assessment Scale (BOAS), and ETT displacement measured using the Endotracheal Tube Slippage Scale. Secondary outcomes include unplanned extubation, ease and time of fixation, need for assistance during application, and time to the development of pressure injury. The findings are expected to provide high-quality evidence to guide the selection of optimal ETT securement methods, improve patient safety, reduce device-related complications, and enhance the quality of critical care nursing practice in elderly trauma patients.
Read the detailed description
Medical device-related pressure injuries (MDRPIs) associated with endotracheal tube (ETT) securement are common complications among mechanically ventilated patients, particularly elderly trauma patients, who are at increased risk due to age-related tissue fragility, impaired tissue perfusion, and prolonged immobilization. In addition to oral mucosal pressure injuries, inadequate ETT fixation may result in tube displacement and unplanned extubation, leading to serious complications such as airway obstruction, hypoxemia, aspiration, reintubation, prolonged mechanical ventilation, and increased healthcare costs. Although several methods are available for securing ETTs, including adhesive tape, gauze, and commercial fixation devices, evidence regarding the optimal securement technique remains limited.
This prospective, three-arm, randomized controlled trial aims to compare the effectiveness of the AnchorFast™ endotracheal tube securement device with conventional adhesive tape and gauze fixation in preventing oral mucosal pressure injuries and reducing ETT dislodgement among mechanically ventilated elderly trauma patients admitted to the intensive care unit (ICU). Ninety eligible patients aged 65 years or older requiring oral endotracheal intubation and expected to receive mechanical ventilation for at least 72 hours will be randomly assigned in a 1:1:1 ratio to one of the three securement methods. Standardized airway management, oral care, and routine repositioning protocols will be implemented for all participants throughout the study period.
The primary outcomes are the incidence and severity of oral mucosal pressure injuries, assessed using the Beck Oral Assessment Scale (BOAS), and endotracheal tube displacement measured using the Endotracheal Tube Slippage Scale. Secondary outcomes include unplanned extubation, fixation time, ease of device application, need for assistance during fixation, number of re-fixations, time to first pressure injury, duration of mechanical ventilation, and ICU length of stay. The study is expected to generate high-quality evidence regarding the safest and most effective ETT securement strategy for elderly trauma patients and support the development of evidence-based protocols aimed at reducing device-related complications, improving
- Conditions
- Elderly, Trauma ICU Patients
- Being tested
- AnchorFast : Endotracheal Tube Securement Device
- Keywords
- Endotracheal tube securement, AnchorFast, Elderly trauma patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnchorFast : Endotracheal Tube Securement DeviceProcedure or surgery
The AnchorFast: endotracheal tube securement device is a single-use commercial device designed to stabilize oral endotracheal tubes while allowing easy repositioning for oral care. It incorporates a tube clamp, lip stabilizer, and adhesive skin barrier pads to minimize tube movement, reduce pressure on oral tissues, and prevent unplanned extubation and medical device-related pressure injuries.
| Study group | Role | What they receive |
|---|---|---|
| experimental arm 1 | Experimental | endotracheal tube securement device. The AnchorFast™ endotracheal tube securement device is a commercially available, single-use device designed to stabilize oral endotracheal tubes while allowing easy tube repositioning for oral care. The device includes a tube clamp, lip stabilizer, and adhesive skin barrier pads to minimize tube movement, reduce pressure on the oral tissues, and decrease the risk of oral mucosal pressure injuries and unplanned extubation. Receives: Procedure: AnchorFast : Endotracheal Tube Securement Device |
| Active Comparator Arm 1 | Active comparator | Conventional adhesive tape securement. The endotracheal tube will be secured using conventional medical adhesive tape applied according to institutional airway management protocols to maintain tube position during mechanical ventilation. Receives: Procedure: AnchorFast : Endotracheal Tube Securement Device |
| Active Comparator Arm 2 | Active comparator | Conventional gauze tape securement.The endotracheal tube will be secured using non-elastic gauze tape wrapped around the tube and fixed according to the institutional protocol to maintain airway stability during mechanical ventilation. Receives: Procedure: AnchorFast : Endotracheal Tube Securement Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Oral Mucosal Pressure Injuries
Oral mucosal pressure injuries will be assessed using the Beck Oral Assessment Scale (BOAS). The scale evaluates the condition of the lips, gingiva, oral mucosa, tongue, teeth/dentures, and saliva. Higher scores indicate poorer oral health and greater severity of oral mucosal injury
Measured: From intubation until extubation or up to 14 days after endotracheal intubation.
Endotracheal Tube (ETT) Dislodgement
Endotracheal tube displacement will be evaluated using the Endotracheal Tube Slippage Scale, which measures the extent of tube movement from the original fixation point and classifies the risk of accidental extubation.
Measured: From intubation until extubation or up to 14 days.
Secondary outcomes (1)
Unplanned Extubation
Number of accidental or self-extubation events occurring during mechanical ventilation.
Measured: During ICU stay (up to 14 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Dec 2025
- Primary completion30 Apr 2026
- Study completion29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norther Private Collage of Nursing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Hashem, Norther Private Collage of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684443
- Sponsor's protocol ID
- Oral Mucosal Pressure Injuries
- Acronym
- mucosal injury
- Status last verified
- Dec 2025
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Mucosal Pressure Injuries and Endotracheal Tube Dislodgement: A Randomized Controlled Trial Comparing Securement Methods in Elderly Trauma Patients
- ClinicalTrials.gov ID
- NCT07684443
- Acronym / sponsor ID
- mucosal injury / Oral Mucosal Pressure Injuries
- Conditions
- Elderly, Trauma ICU Patients
- Keywords
- Endotracheal tube securement, AnchorFast, Elderly trauma patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Norther Private Collage of NursingUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 6 Jul 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.
This randomized controlled trial aims to compare the effectiveness of the AnchorFast™ endotracheal tube (ETT) securement device with conventional adhesive tape and gauze fixation in preventing oral mucosal pressure injuries and endotracheal tube dislodgement among mechanically ventilated elderly trauma patients admitted to the intensive care unit. A total of 90 patients aged 65 years and older requiring oral endotracheal intubation will be randomly allocated to one of the three securement methods. The primary outcomes are the incidence and severity of oral mucosal pressure injuries, assessed using the Beck Oral Assessment Scale (BOAS), and ETT displacement measured using the Endotracheal Tube Slippage Scale. Secondary outcomes include unplanned extubation, ease and time of fixation, need for assistance during application, and time to the development of pressure injury. The findings are expected to provide high-quality evidence to guide the selection of optimal ETT securement methods, improve patient safety, reduce device-related complications, and enhance the quality of critical care nursing practice in elderly trauma patients.
Detailed description
Medical device-related pressure injuries (MDRPIs) associated with endotracheal tube (ETT) securement are common complications among mechanically ventilated patients, particularly elderly trauma patients, who are at increased risk due to age-related tissue fragility, impaired tissue perfusion, and prolonged immobilization. In addition to oral mucosal pressure injuries, inadequate ETT fixation may result in tube displacement and unplanned extubation, leading to serious complications such as airway obstruction, hypoxemia, aspiration, reintubation, prolonged mechanical ventilation, and increased healthcare costs. Although several methods are available for securing ETTs, including adhesive tape, gauze, and commercial fixation devices, evidence regarding the optimal securement technique remains limited.
This prospective, three-arm, randomized controlled trial aims to compare the effectiveness of the AnchorFast™ endotracheal tube securement device with conventional adhesive tape and gauze fixation in preventing oral mucosal pressure injuries and reducing ETT dislodgement among mechanically ventilated elderly trauma patients admitted to the intensive care unit (ICU). Ninety eligible patients aged 65 years or older requiring oral endotracheal intubation and expected to receive mechanical ventilation for at least 72 hours will be randomly assigned in a 1:1:1 ratio to one of the three securement methods. Standardized airway management, oral care, and routine repositioning protocols will be implemented for all participants throughout the study period.
The primary outcomes are the incidence and severity of oral mucosal pressure injuries, assessed using the Beck Oral Assessment Scale (BOAS), and endotracheal tube displacement measured using the Endotracheal Tube Slippage Scale. Secondary outcomes include unplanned extubation, fixation time, ease of device application, need for assistance during fixation, number of re-fixations, time to first pressure injury, duration of mechanical ventilation, and ICU length of stay. The study is expected to generate high-quality evidence regarding the safest and most effective ETT securement strategy for elderly trauma patients and support the development of evidence-based protocols aimed at reducing device-related complications, improving
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| experimental arm 1 | Experimental | Procedure: AnchorFast : Endotracheal Tube Securement Deviceendotracheal tube securement device. The AnchorFast™ endotracheal tube securement device is a commercially available, single-use device designed to stabilize oral endotracheal tubes while allowing easy tube repositioning for oral care. The device includes a tube clamp, lip stabilizer, and adhesive skin barrier pads to minimize tube movement, reduce pressure on the oral tissues, and decrease the risk of oral mucosal pressure injuries and unplanned extubation. |
| Active Comparator Arm 1 | Active comparator | Procedure: AnchorFast : Endotracheal Tube Securement DeviceConventional adhesive tape securement. The endotracheal tube will be secured using conventional medical adhesive tape applied according to institutional airway management protocols to maintain tube position during mechanical ventilation. |
| Active Comparator Arm 2 | Active comparator | Procedure: AnchorFast : Endotracheal Tube Securement DeviceConventional gauze tape securement.The endotracheal tube will be secured using non-elastic gauze tape wrapped around the tube and fixed according to the institutional protocol to maintain airway stability during mechanical ventilation. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
Key exclusion criteria (11 listed)
- Extubation:
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 |
|---|---|---|
| AnchorFast : Endotracheal Tube Securement DeviceThe AnchorFast: endotracheal tube securement device is a single-use commercial device designed to stabilize oral endotracheal tubes while allowing easy repositioning for oral care. It incorporates a tube clamp, lip stabilizer, and adhesive skin barrier pads to minimize tube movement, reduce pressure on oral tissues, and prevent unplanned extubation and medical device-related pressure injuries. | Procedure or surgery | Active Comparator Arm 1, Active Comparator Arm 2, experimental arm 1 |
Primary outcome
Incidence and Severity of Oral Mucosal Pressure Injuries
Time frame: From intubation until extubation or up to 14 days after endotracheal intubation.
Oral mucosal pressure injuries will be assessed using the Beck Oral Assessment Scale (BOAS). The scale evaluates the condition of the lips, gingiva, oral mucosa, tongue, teeth/dentures, and saliva. Higher scores indicate poorer oral health and greater severity of oral mucosal injury
Endotracheal Tube (ETT) Dislodgement
Time frame: From intubation until extubation or up to 14 days.
Endotracheal tube displacement will be evaluated using the Endotracheal Tube Slippage Scale, which measures the extent of tube movement from the original fixation point and classifies the risk of accidental extubation.
1 secondary outcome
Unplanned Extubation
Time frame: During ICU stay (up to 14 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AnchorFast : Endotracheal Tube Securement Device in people with Elderly and Trauma ICU Patients, run by Norther Private Collage of Nursing at 1 site in Saudi Arabia.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Oral Mucosal Pressure Injuries (time frame: From intubation until extubation or up to 14 days after endotracheal intubation.). The study lists 2 primary outcomes in all. 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 6 Jul 2026.