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治験 NCT07390162 (PreventionMMPI)（対象：Mucosal Wound、Mucosal Erosion、Mucosal Irritation、Endotracheal Intubation Fixation、Endotracheal Tube Position、Repositioning、Intensive Care Units (ICUs)、Adult Patients、Pressure Ulcer Prevention）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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ハジェテペ大学The Effect of Changes in the Frequency of Endotracheal Tube Repositioning in Intensive Care Units on the Prevention of Oral Mucosal Pressure Injuries (PreventionMMPI) 230 国際共同 医療機器 予防
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治験番号 NCT07390162 (PreventionMMPI) は 介入研究 臨床試験 で、Mucosal Wound、Mucosal Erosion、Mucosal Irritation、Endotracheal Intubation Fixation、Endotracheal Tube Position、Repositioning、Intensive Care Units (ICUs)、Adult Patients、Pressure Ulcer Prevention に関するものです。現在は 募集準備中 で、2026年5月30日 に開始予定です。230 名の参加者 の募集が計画されています。この試験は ハジェテペ大学 によって主導され、2027年6月15日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月17日 です。
概要
Intensive care units (ICUs) are care centers equipped with a wide range of technological tools and devices used to provide the highest level of care to individuals whose lives are at risk, requiring a multidisciplinary team approach. Patients may require respiratory support from a ventilator to maintain breathing. In the intensive care unit, patients' breathing is maintained using a medical device called an endotrach...もっと見る
詳細説明
In the study, the legal representative of the volunteer will be informed in such a case, and the routine tube repositioning schedule (twice a day, every 12 hours) of the intensive care unit will be resumed. The study is being conducted to shorten the frequency of tube repositioning and to prevent oral mucosal pressure injuries. In accordance with Law No. 6698 on the Protection of Personal Data, the volunteers' names,...もっと見る
公式タイトル
The Effect of Changes in the Frequency of Endotracheal Tube Repositioning in Intensive Care Units on the Prevention of Oral Mucosal Pressure Injuries
疾患名
Mucosal WoundMucosal ErosionMucosal IrritationEndotracheal Intubation FixationEndotracheal Tube PositionRepositioningIntensive Care Units (ICUs)Adult PatientsPressure Ulcer Prevention刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- PreventionMMPI
- 2025/07-02 (KA-24086)-D-Number
- 2025/07-02 (KA-24086)-D-Number (登録識別子) (Turkish Medicines and Medical Devices Agency Ministry of Health of the Republic of Turkey)
- Clinical Research Ethics C. (その他の識別子) (Turkish Medicines and Medical Devices Agency Ministry of Health of the Republic of Turkey & Hacettepe University)
NCT番号
開始日
2026-05-30
最終更新日
2026-03-17
終了予定日
2027-06-15
目標参加者数
230
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集準備中
キーワード
mucosal membrane pressure injury
Intensive Care Units (ICUs)
Endotracheal intubation fixation
Repositioning
pressure ulcer prevention
Intensive Care Units (ICUs)
Endotracheal intubation fixation
Repositioning
pressure ulcer prevention
主目的
予防
割付方法
無作為化
介入モデル
並行割当
盲検化
二重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的APACHE II score ≤20 Patients | Changes in the frequency of endotracheal tube repositioning Ensuring changes in the frequency of endotracheal tube repositioning (two experimental groups of 4 and 8 hours) |
実験的APACHE II score 20-24 Patients | Changes in the frequency of endotracheal tube repositioning Ensuring changes in the frequency of endotracheal tube repositioning (two experimental groups of 4 and 8 hours) |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Oral mucosal pressure injury formation | Oral mucosal pressure injury formation was accepted as the primary outcome variable in the study. | The first 14 days of monitoring |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- The study will include patients over the age of 18, receiving MV support with oral ETT, with no tissue loss/damage in the oral mucosa at the time of admission to the ICU, who have been intubated for less than 24 hours, with an APACHE II score ≤24, and whose first-degree relatives have given consent for their participation in the study.
Patients meeting any of the following criteria will not be included in the study:
- Differences in respiratory support: Patients receiving non-invasive ventilatory support via face mask or nasal cannula (CPAP or BiPAP), as ETT-related mucosal pressure does not occur.
- Pre-existing artificial airway: Patients with a tracheostomy prior to study enrollment, due to anatomical differences and the inability to apply ETT securement methods.
- Oncological conditions: Oncology patients receiving active chemotherapy, due to increased mucositis risk and impaired tissue healing.
- Neurological and behavioral factors: Patients with recurrent seizures, an uncontrolled biting reflex, or those who bite the ETT, as these increase the risk of mechanical trauma.
- Positional constraints: Patients managed in the prone position due to clinical status, as this invalidates standard ETT securement and mucosal assessment protocols.
- Sensory/perceptual impairment: Patients with severe neurological impairment affecting pain perception and tissue response.
- Pre-existing injury: Patients who have an oral mucosal pressure injury of Stage 2 or higher at baseline assessment.
Withdrawal Criteria
Patients will be withdrawn from the study under the following circumstances:
- Withdrawal of consent: The patient's legal representative withdraws consent after enrollment.
- Airway change: The patient is extubated or converted to tracheostomy during follow-up, as the intervention field is no longer present.
- Transfer or death: The patient dies or is transferred to another unit/hospital before completion of the 14-day follow-up period.
- Data loss/non-adherence: Due to clinical circumstances (e.g., emergency surgery, prolonged imaging), two consecutive interventions cannot be performed, or physiological data remain incomplete.
ハジェテペ大学責任者
Ecem Ozdemir, 主任研究者, Research Assistant, Hacettepe University
試験中央連絡先
連絡先: Ecem Research Assistant, +905427306671, [email protected]
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