Japanese, multicenter, randomized controlled trial of noninvasive positive pressure ventilation (NPPV) versus high-flow nasal cannula oxygen therapy (HFNC) for acute hypoxemic respiratory failure - Study of NPPV versus HFNC for acute hypoxemic respiratory failure (Ja-NP-Hi trial)

Kobe City Medical Center General Hospital Department of Respiratory Medicine0 个研究点目标入组 104 人开始时间: 2017年8月25日最近更新: 2023年10月17日

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 ot applicable（—）
性别: All

入选标准

未提供

排除标准

•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.

研究者

发起方

Kobe City Medical Center General Hospital Department of Respiratory Medicine

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