EFFECT OF A NURSING CARE BUNDLE ON MEDICAL DEVICE-RELATED ORAL MUCOSAL MEMBRANE PRESSURE INJURIES IN INTENSIVE CARE PATIENTS
研究概览
详细说明
The EPUAP (European Pressure Ulcer Advisory Panel) defines pressure ulcers as "Pressure injuries are localized injuries to the skin and/or underlying tissue, usually over a bony prominence, resulting from sustained pressure." The National Pressure Injury Advisory Panel (NPIAP) in the United States defines medical device-related pressure injuries as "results in the use of devices designed and applied for diagnostic or therapeutic purposes." In 2019, the term 'medical device-related pressure injury' (MDRPI) was changed to 'device-related pressure injury' (DRPI), a concept that defines the cause of the injury. Mucosal membrane pressure injury (MMPI) is a type of Medical Device-Related Pressure Injury. Mucosal membrane pressure injury (MMPI) is defined by the NPIAP as localized tissue damage occurring in mucous membranes in association with the use of a medical device (endotracheal tube, nasogastric tube, urinary catheter, etc.). Biomechanically, these injuries; MMPI develops as a result of continuous vertical pressure, friction, and shear forces applied to the mucosa by medical devices, leading to tissue ischemia and hypoxia (Amrani and Gefen, 2020). Oral endotracheal tube-associated mucosal pressure injury (OETMMPI) refers to pressure injuries (PI) occurring in the lips or oral mucosa due to pressure from endotracheal tube fixators (Yiğitoğlu & Aydoğan, 2023).
Especially in intensive care units (ICUs), dependence on life-saving medical devices and the loss of consciousness or mobility of patients expose them to a very high risk of MMPI (Cuddigan et al., 2022). Current comprehensive reviews in the literature show that the incidence of MMPI in critically ill patients can range from 0.83% to 88.2%, and the prevalence from 0.16% to 55.6%, with the most frequently affected area being the oral mucosa (Chen et al., 2024). A 5-year retrospective analysis reported that while the overall hospital rate for device-related mucosal injury was 0.1%, this rate was approximately 70 times higher (2.4%) in ICU patients, with 70.3% of cases originating from endotracheal tubes (Fulbrook et al., 2023). According to a 2025 study by Chen et al., approximately half of orotracheal endotracheal tube-related mucosal pressure injuries (OETMMPI) developed on the second day of intubation, with an average occurrence time of the fourth day. Therefore, it was emphasized that ICU patients expected to remain intubated for more than four days should be particularly protected. In conclusion, oral mucosal membrane pressure injuries, which occur with a high incidence in intubated ICU patients, are a significant problem that increases patient pain, raises the risk of infection (e.g., ventilator-associated pneumonia), and leads to worsening of the clinical picture (Chen et al., 2024). To prevent these injuries, early identification of risk factors, regular oral mucosal assessments at the beginning of each shift, and integration of evidence-based nursing care packages into clinical routine are critical requirements (Chen et al., 2024; Özdemir and Kavaklı, 2025). According to a 2025 study by Gao et al., intensive care nurses' knowledge and behavior regarding the OETMMPI were at a moderate level and needed improvement. For all these reasons, preventing these injuries is a crucial aspect of intensive care nursing. The study is planned to be conducted in two parallel tertiary intensive care units at Eskişehir Yunus Emre State Hospital and is a randomized experimental study with a control group. Routine care practices will be continued in one intensive care unit (control group), while an evidence-based standardized care package will be applied in the other (intervention group). The research will not involve any invasive procedures; oral care will be performed. The intervention applied is the standardization of existing nursing care with evidence-based practices. Scale-based assessments will be conducted. Data will be analyzed using appropriate statistical methods. The study sample will consist of mechanically ventilated, intubated patients over 18 years of age with no known oral mucosal disease or cancer history.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:ÖZLEM DOĞU, Assoc.Prof.
- 电话号码:05056792063
- 邮箱:ozlemdogu@sakarya.edu.tr
研究联系人备份
- 姓名:Serap YILMAZTÜRK, Nurse
- 电话号码:05057104770
- 邮箱:serapotar@gmail.com
学习地点
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Zzz_not_valid_zzz
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Eskişehir、Zzz_not_valid_zzz、土耳其(türkiye)、26100
- Eskişehir Yunus Emre State Hospital
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接触:
- serap Yılmaztürk, Nurse
- 电话号码:05057104770
- 邮箱:serapotar@gmail.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Receiving inpatient treatment in a tertiary intensive care unit Orotracheally intubated and receiving invasive mechanical ventilation support Aged 18 years or older Informed consent provided by the patient's legal representative
Exclusion Criteria:
- Aged under 18 years History of malignant disease (cancer) History of known oral mucosal disease Refusal of informed consent
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Intervention Group
Experimental.
Mechanically ventilated adult patients will receive a standardized evidence-based oral care bundle developed to prevent oral mucosal membrane pressure injuries associated with orotracheal endotracheal tubes.
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A standardized evidence-based nursing oral care bundle will be implemented for mechanically ventilated, orotracheally intubated adult intensive care patients.
The bundle will include standardized oral care practices developed from current evidence and expert review, with the aim of reducing the incidence and delaying the development of oral mucosal membrane pressure injuries associated with endotracheal tube use.
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无干预:Control Group
Active Comparator.
Patients will receive the routine oral care practices currently provided in the intensive care unit.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of Oral Mucosal Membrane Pressure Injury
大体时间:From enrollment until completion of the 7-day follow-up period
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Incidence of oral mucosal membrane pressure injury associated with orotracheal endotracheal tube use, assessed using the Modified Reaper Oral Mucosal Pressure Injury Scale (M-ROMPIS).
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From enrollment until completion of the 7-day follow-up period
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Severity of Oral Mucosal Membrane Pressure Injury
大体时间:7-day follow-up period.
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Severity of Oral Mucosal Membrane Pressure Injury - Severity assessed using M-ROMPIS during the 7-day follow-up period.
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7-day follow-up period.
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- E-43012747-050.04-590393-418
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