- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07775027
EFFECT OF A NURSING CARE BUNDLE ON MEDICAL DEVICE-RELATED ORAL MUCOSAL MEMBRANE PRESSURE INJURIES IN INTENSIVE CARE PATIENTS
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: ÖZLEM DOĞU, Assoc.Prof.
- Número de teléfono: 05056792063
- Correo electrónico: ozlemdogu@sakarya.edu.tr
Copia de seguridad de contactos de estudio
- Nombre: Serap YILMAZTÜRK, Nurse
- Número de teléfono: 05057104770
- Correo electrónico: serapotar@gmail.com
Ubicaciones de estudio
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Eskişehir, Zzz_not_valid_zzz, Turquía (Türkiye), 26100
- Eskişehir Yunus Emre State Hospital
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Contacto:
- serap Yılmaztürk, Nurse
- Número de teléfono: 05057104770
- Correo electrónico: serapotar@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Sin intervención: Control Group
Active Comparator.
Patients will receive the routine oral care practices currently provided in the intensive care unit.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence of Oral Mucosal Membrane Pressure Injury
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Severity of Oral Mucosal Membrane Pressure Injury
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- E-43012747-050.04-590393-418
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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