- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07775027
EFFECT OF A NURSING CARE BUNDLE ON MEDICAL DEVICE-RELATED ORAL MUCOSAL MEMBRANE PRESSURE INJURIES IN INTENSIVE CARE PATIENTS
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: ÖZLEM DOĞU, Assoc.Prof.
- Telefonnummer: 05056792063
- E-mail: ozlemdogu@sakarya.edu.tr
Undersøgelse Kontakt Backup
- Navn: Serap YILMAZTÜRK, Nurse
- Telefonnummer: 05057104770
- E-mail: serapotar@gmail.com
Studiesteder
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Eskişehir, Zzz_not_valid_zzz, Tyrkiet (Türkiye), 26100
- Eskişehir Yunus Emre State Hospital
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Kontakt:
- serap Yılmaztürk, Nurse
- Telefonnummer: 05057104770
- E-mail: serapotar@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Ingen indgriben: Control Group
Active Comparator.
Patients will receive the routine oral care practices currently provided in the intensive care unit.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of Oral Mucosal Membrane Pressure Injury
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Severity of Oral Mucosal Membrane Pressure Injury
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- E-43012747-050.04-590393-418
Plan for individuelle deltagerdata (IPD)
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