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

NCT07684443 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-07-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Norther Private Collage of Nursing

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-04-30
Completion
2026-05-29

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07684443 on ClinicalTrials.gov