Oral Mucosal Pressure Injuries and Endotracheal Tube Dislodgement Among Elderly Trauma Patients (mucosal injury)
Oral Mucosal Pressure Injuries and Endotracheal Tube Dislodgement: A Randomized Controlled Trial Comparing Securement Methods in Elderly Trauma Patients
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Arar, Саудовская Аравия
- Norther Private Colleague of Nursing
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
Inclusion Criteria
- 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
Exclusion Criteria:
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: experimental arm 1
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.
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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.
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Активный компаратор: Active Comparator Arm 1
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.
|
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.
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Активный компаратор: Active Comparator Arm 2
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.
|
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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Incidence and Severity of Oral Mucosal Pressure Injuries
Временное ограничение: From intubation until extubation or up to 14 days after endotracheal intubation.
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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
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From intubation until extubation or up to 14 days after endotracheal intubation.
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Endotracheal Tube (ETT) Dislodgement
Временное ограничение: From intubation until extubation or up to 14 days.
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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.
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From intubation until extubation or up to 14 days.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Unplanned Extubation
Временное ограничение: During ICU stay (up to 14 days).
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Number of accidental or self-extubation events occurring during mechanical ventilation.
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During ICU stay (up to 14 days).
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Соавторы и исследователи
Публикации и полезные ссылки
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- Oral Mucosal Pressure Injuries
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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