Impact of Nasal High-flow vs Venturi Mask Oxygen Therapy on Weaning Outcome: a Multicenter, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 15
- 主要终点
- Reintubation
研究概览
简要总结
The purpose of this study is to determine whether, as compared with the Venturi mask, a nasal, high-flow oxygenation device (Optiflow) may reduce the extubation failure rate in patients needing oxygen therapy after extubation.
详细描述
This study compares the effects of two devices for oxygen therapy, the nasal, high-flow (Optiflow, intervention) and the Venturi mask (control), on the outcome of extubation. Available data suggest that Optiflow can improve oxygenation and patient's comfort in critically ill patients after extubation. The study hypothesis is that Optiflow may reduce the extubation failure rate in these patients.
In the intervention group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive high-flow oxygen through nasal cannula (Optiflow, Fisher & Paykel Healthcare Ltd., New Zealand) after extubation. The oxygen concentration (FiO2) will be set to reach an oxygenation target similar to control patients (see below), while the gas flow rate will be set at 50 L/min.
In the control group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive oxygen through a standard Venturi mask after extubation. The FiO2 will be set to obtain a arterial oxygen saturation (SpO2) between 92% and 98% (or between 88% and 95% in hypercapnic patients). Further FiO2 modifications will be performed by the attending physicians to meet the oxygenation target.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Mechanical ventilation > 24 hours
- •Signed Informed Consent
- •Successful spontaneous breathing trial
- •PaO2/FiO2 ratio ≤ 300 (or SpO2/FiO2 ratio ≤ 300 if SpO2 is lower than 98%) within 30 min after extubation while breathing through a Venturi mask with a delivered FiO2 of 31%
排除标准
- •Presence of tracheostomy
- •Need for immediate post-extubation Non-Invasive Ventilation (>3 consecutive failures of the spontaneous breathing trial and/or a PaCO2 > 45 mmHg before the spontaneous breathing trial, with a respiratory rate ≥ 25/min)
研究组 & 干预措施
Nasal high-flow oxygen therapy
High-flow, fully humidified oxygen delivered through nasal cannula (Optiflow, Fisher & Paykel Healthcare) after extubation up to ICU discharge
干预措施: Optiflow (Fisher & Paykel Healthcare) (Device)
Venturi mask oxygen therapy
Oxygen delivered through standard Venturi mask after extubation up to ICU discharge
干预措施: Venturi mask (Device)
结局指标
主要结局
Reintubation
时间窗: within 72 hours after extubation or at ICU discharge
次要结局
- Need for Non-Invasive Ventilation(at day 28 after inclusion in the study or at ICU discharge)
- ICU length of stay(at day 28 from the inclusion in the study or at ICU discharge)
- ICU readmission(at day 28 from inclusion in the study)
- ICU mortality(at day 28 from inclusion in the study)
- Hospital mortality(at day 28 from inclusion in the study)
- Hospital length of stay(at day 28 from the inclusion in the study or at hospital discharge)
研究者
Salvatore Maurizio MAGGIORE, MD, PhD
Associate Professor
Catholic University of the Sacred Heart