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COMPLETED
NCT07684443
NA

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

Sponsor: Norther Private Collage of Nursing

View on ClinicalTrials.gov

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.

Official title: Oral Mucosal Pressure Injuries and Endotracheal Tube Dislodgement: A Randomized Controlled Trial Comparing Securement Methods in Elderly Trauma Patients

Key Details

Gender

All

Age Range

65 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2025-12-01

Completion Date

2026-05-29

Last Updated

2026-07-06

Healthy Volunteers

No

Interventions

PROCEDURE

AnchorFast : Endotracheal Tube Securement Device

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.

Locations (1)

Norther Private Colleague of Nursing

Arar, Saudi Arabia