Oral Mucosal Pressure Injuries and Endotracheal Tube Dislodgement Among Elderly Trauma Patients

NCT07684443 | Completed DMC

• 1 other identifier: Oral Mucosal Pressure Injuries
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Elderly; Trauma ICU Patients

Keywords

Endotracheal tube securement, AnchorFast, Elderly trauma patients

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  From intubation until extubation or up to 14 days.

Secondary Outcomes (1)

• Unplanned Extubation

  During ICU stay (up to 14 days).

Study Arms (3)

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.

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.

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.

Procedure: AnchorFast : Endotracheal Tube Securement Device

Interventions

AnchorFast : Endotracheal Tube Securement Device PROCEDURE

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.

Active Comparator Arm 1; Active Comparator Arm 2; experimental arm 1

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Norther Private Collage of Nursing: lead

Study Sites (1)

Norther Private Colleague of Nursing

Arar, Saudi Arabia

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: December 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: May 29, 2026
• Last Updated: July 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)