本邦における急性Ⅰ型呼吸不全に対する非侵襲的人工呼吸器（NPPV）と高流量鼻カニュラ酸素療法（HFNC）の多施設ランダム化比較試験

試験ID UMIN000028827

最終情報更新日：2022年3月4日

基本情報

• 試験ID: UMIN000028827
• 研究名称 / Scientific Title（Acronym）: 本邦における急性Ⅰ型呼吸不全に対する非侵襲的人工呼吸器（NPPV）と高流量鼻カニュラ酸素療法（HFNC）の多施設ランダム化比較試験
• 研究名称 / Scientific Title（Acronym）: Japanese, multicenter, randomized controlled trial of noninvasive positive pressure ventilation (NPPV) versus high-flow nasal cannula oxygen therapy (HFNC) for acute hypoxemic respiratory failure
• 平易な研究名称 / Public Title（Acronym）: Japanese, multicenter, randomized controlled trial of noninvasive positive pressure ventilation (NPPV) versus high-flow nasal cannula oxygen therapy (HFNC) for acute hypoxemic respiratory failure
• 試験進捗状況/Recruitment status: 試験終了
• 試験進捗状況/Recruitment status: Complete: follow-up complete
• 登録日時: 2017年8月25日
• 最終情報更新日: 2022年3月4日

試験概要

• 試験実施地域 / Region: 日本
• 試験実施地域 / Region: Japan
• 目標症例数/Target sample size: 104
• 対象疾患 / Health condition(s) or Problem(s) studied: 急性Ⅰ型呼吸不全
• 対象疾患 / Health condition(s) or Problem(s) studied: acute hypoxemic respiratory failure
• 試験のタイプ / Study type: 介入
• 試験のタイプ / Study type: Interventional
• 介入1: A群（NPPV）：プロトコル治療としてNPPVを用いる。
• 介入2: B群（HFNC）：プロトコル治療としてHFNCを用いる。
• 主要評価項目 / Primary outcomes: 治療開始28日間での挿管基準を満たすまでの期間
• 主要評価項目 / Primary outcomes: Term from randomization to meeting criteria for endotracheal intubation censored at 28 days.
• 副次評価項目 / Secondary outcomes: 1. Proportion of patients who required endotracheal intubation within 28 days after randomization. 2. Mortality at 28 days 3. In-hospital mortality 4. Ventilator-free days 5. Change of oxygenation (PaO2/FIO2) 6. Arterial blood gas analysis 7. Duration of need for any respiratory support 8. Duration of hospital stay for respiratory illness 9. Adverse events 10. Need for Continuous sedation (Drug, dose, duration)

適格性

• 年齢（下限）/ Age minimum: 20歳以上
• 年齢（下限）/ Age minimum: 20years-old
• 年齢（上限）/ Age maximum: Not applicable
• 性別 / Gender: 男女両方
• 性別 / Gender: Male and Female
• 除外基準 / Exclude criteria: 1. Patients with urgent need for endotracheal intubation. 2. Patients with respiratory failure fully explained by cardiac failure or fluid overload. 3. Patients with COVID-19. 4. Patients with exacerbation of asthma. 5. Patients with pulmonary embolism. 6. Patients who have received NPPV or HFNC for more than 24 hours at the time of the informed consent. 7. Patients who have the following chronic pulmonary disease. a. Chronic interstitial pneumonia apparent on chest radiography. b. Chronic pulmonary disease affecting the efficacy endpoints (for example; COPD, tuberculosis sequelae, bronchiectasis, pneumoconiosis etc.). c. Chronic respiratory failure with need for home oxygen therapy (more than 12 hours/day). d. Chronic pulmonary disease that are regarded as inadequate for the study by the investigators. 8. Patients with active malignant tumor affecting the efficacy endpoints. 9. Patients with contraindications either to NPPV or HFNC, such as undrained pneumothorax, upper airway obstruction, facial trauma, injury and deformity etc. 10. Patients with major surgery within 4 weeks prior to the time of the informed consent. 11. Patients with severe leukopenia (WBC < 1000 per microliter of blood). 12. Patients with hemodynamic instability (systolic blood pressure < 90 mmHg after fluid administration). 13. Patients with need for vasopressors. 14. Patients with altered consciousness (Glasgow Coma Scale <= 12 points. 15. Patients who have received NPPV or HFNC within the past 4 weeks prior to the informed consent, or are using NPPV or HFNC at home (more than 6 hours/day). 16. Patients with tracheostomy. 17. Patients who are pregnant. 18. Patients with cognitive impairment or mental disorder who are regarded as inadequate to evaluate for the study by the investigators. 19. Patients who have participated in the other study at the time of the informed consent, or will participate in the other study. 20. Any other cases who are regarded as inadequate for the study enrollment.

責任研究者

• 責任研究者 / Name of lead principal investigator: Keisuke Tomii
• 部署名 / Division: Kobe City Medical Center General Hospital Department of Respiratory Medicine
• 住所 / Address: 2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe Japan
• 電話 / Telephone: [phone]
• 実施責任組織 / Affiliation: 神戸市立医療センター中央市民病院呼吸器内科
• 実施責任組織 / Affiliation: Kobe City Medical Center General Hospital Department of Respiratory Medicine
• 研究費提供組織 / Funding Source: Philips Respironics

試験問い合わせ窓口

• 住所 / Address: 2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe Japan
• 電話 / Telephone: [phone]
• E-mail: [e-mail]
• 担当者 / Name of contact person: Kazuma Nagata