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This randomized controlled trial aims to compare the effectiveness of the AnchorFastâ„¢ 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.
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 AnchorFastâ„¢ 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental arm 1 | Experimental | endotracheal tube securement device. The AnchorFastâ„¢ 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Unplanned Extubation | Number of accidental or self-extubation events occurring during mechanical ventilation. | During ICU stay (up to 14 days). |
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Inclusion Criteria:
Inclusion Criteria
Exclusion Criteria:
Extubation:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norther Private Colleague of Nursing | Arar | Saudi Arabia |
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| Related Info | View source |
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