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EFFECT OF A NURSING CARE BUNDLE ON MEDICAL DEVICE-RELATED ORAL MUCOSAL MEMBRANE PRESSURE INJURIES IN INTENSIVE CARE PATIENTS

2026年8月15日 更新者:özlem doğu、Sakarya University
This research was designed as a randomized controlled experimental study to evaluate the effect of a care package, created by combining evidence-based nursing interventions, on the development of oral mucosal membrane pressure injury in mechanically ventilated and intubated patients in tertiary intensive care units. The study aimed to determine the role of the standardized care package in reducing the development of oral mucosal damage compared to routine care practices.

調査の概要

状態

まだ募集していません

詳細な説明

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.

研究の種類

介入

入学 (推定)

40

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

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      • Eskişehir、Zzz_not_valid_zzz、トルコ(Türkiye)、26100
        • Eskişehir Yunus Emre State Hospital
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
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.
介入なし:Control Group
Active Comparator. Patients will receive the routine oral care practices currently provided in the intensive care unit.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Incidence of Oral Mucosal Membrane Pressure Injury
時間枠:From enrollment until completion of the 7-day follow-up period
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).
From enrollment until completion of the 7-day follow-up period

二次結果の測定

結果測定
メジャーの説明
時間枠
Severity of Oral Mucosal Membrane Pressure Injury
時間枠:7-day follow-up period.
Severity of Oral Mucosal Membrane Pressure Injury - Severity assessed using M-ROMPIS during the 7-day follow-up period.
7-day follow-up period.

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出版物と役立つリンク

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2026年11月30日

研究の完了 (推定)

2026年11月30日

試験登録日

最初に提出

2026年8月15日

QC基準を満たした最初の提出物

2026年8月15日

最初の投稿 (実際)

2026年8月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月19日

QC基準を満たした最後の更新が送信されました

2026年8月15日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • E-43012747-050.04-590393-418

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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