jRCTs052180236已完成不适用
Japanese, multicenter, randomized controlled trial of noninvasive positive pressure ventilation (NPPV) versus high-flow nasal cannula oxygen therapy (HFNC) for severe acute hypoxemic respiratory failure (Ja-NP-Hi trial)
未提供0 个研究点目标入组 104 人开始时间: 2018年1月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients who have acute respiratory failure, which occures within 1 week of a known clinical insult or new or worsening respiratory symptoms.
- •Patients who have new infiltrates on chest radiography.
- •Patients with PaO2/FIO2 < 300 at screening.
- •Patients with PaCO2 <= 45 Torr at screening.
- •Patients who are more than 20 years old at the time of the informed consent.
- •Patients who agree to participate in the study with the written informed consent.
排除标准
- •Patients with urgent need for endotracheal intubation.
- •Patients with respiratory failure fully explained by cardiac failure or fluid overload.
- •Patients with COVID-
- •Patients with exacerbation of asthma.
- •Patients with pulmonary embolism.
- •Patients who have received NPPV or HFNC for more than 24 hours at the time of the informed consent.
- •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.
- •Patients with active malignant tumor affecting the efficacy endpoints.
- •Patients with contraindications either to NPPV or HFNC, such as undrained pneumothorax, upper airway obstruction, facial trauma, injury and deformity etc.
- •Patients with major surgery within 4 weeks prior to the time of the informed consent.
- •Patients with severe leukopenia (WBC < 1000 per microliter of blood).
- •Patients with hemodynamic instability (systolic blood pressure < 90 mmHg after fluid administration).
- •Patients with need for vasopressors.
- •Patients with altered consciousness (Glasgow Coma Scale <= 12 points.
- •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).
- •Patients with tracheostomy.
- •Patients who are pregnant.
- •Patients with cognitive impairment or mental disorder who are regarded as inadequate to evaluate for the study by the investigators.
- •Patients who have participated in the other study at the time of the informed consent, or will participate in the other study.
- •Any other cases who are regarded as inadequate for the study enrollment by the investigators.
结局指标
主要结局
-
Term from randomization to meeting criteria for endotracheal intubation censored at 28 days.
次要结局
- Proportion of patients who required endotracheal intubation(28 days after randomization)
- Mortality(28 days)
- In-hospital mortality
- Ventilator-free days
- Change of oxygenation
- Arterial blood gas analysis
- Duration of need for any respiratory support
- Duration of hospital stay for respiratory illness
- Adverse events
- Need for Continuous sedation
研究者
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