Elderly, Trauma ICU Patients
Conditions
Keywords
Endotracheal tube securement, AnchorFast, Elderly trauma patients
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.
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
Interventions
PROCEDUREAnchorFast : 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
Norther Private Collage of Nursing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria 1. Age ≥65 years old and more. 2. Newly admission to trauma ICU following traumatic injury 3. Patient attached with EET and mechanical ventilation 4. Expected duration of mechanical ventilation for 72 hours and more. 5. Hemodynamically stable (MAP ≥65 mmHg with or without vasopressors) 6. Informed consent obtained from patient or legally authorized representative 7. Enrollment within 6 hours of intubation
Exclusion criteria
* Extubation: 1. Pre-existing tracheostomy and planned tracheostomy within 72 hours 2. Patients with facial trauma or facial burns or active facial skin. 3. Known allergy to adhesive materials or device components 4. Active facial skin infection or significant dermatologic condition 5. Enrollment in another interventional study 6. Do-not-resuscitate status or comfort care designation 7. Expected survival less than 72 hours based on clinical judgment 8. Oral surgery or oral infection or inflammation. 9. A previous neck injury, projecting upper teeth, or the absence of teeth. 10. Radiotherapy-induced oral mucositis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Oral Mucosal Pressure Injuries | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned Extubation | During ICU stay (up to 14 days). | Number of accidental or self-extubation events occurring during mechanical ventilation. |
Countries
Saudi Arabia
Outcome results
None listed