ROX Index Compared to Standard of Care for the Timing of Intubation in Patients Supported by Nasal High Flow: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 630
- 试验地点
- 16
- 主要终点
- Early intubation
研究概览
简要总结
Late or delayed intubation in patients with acute hypoxemic respiratory failure (AHRF) treated with nasal high flow (NHF) is associated with increased patient mortality. The ROX index has been designed and validated to predict outcome of NFH therapy by identifying those patients with a high risk of NHF failure and those with a high probability of success. Whether or not the ROX index may improve patient outcome remains to be shown. To do so, a strategy using the ROX index must lead to earlier intubation than commonly-used criteria.
The objective of the ROX-1 trial is to assess whether the use of an algorithm incorporating the ROX index to standard of care for the time to intubation in patients with AHRF supported with NHF isassociated with an increase in the proportion of patients who are intubated within the first 12 hours among those patients who fail on NHF.
详细描述
This is a pilot study to assess whether the use of an algorithm incorporating the ROX index to traditional criteria for intubation in patients with AHRF supported with NHF is:(i) feasible; (ii) associated with a decreased time to intubation.
The ROX-1 trial is an international, multicenter, parallel, open-label randomized controlled two-arm trial that will be performed in patients with AHRF, supported by nasal high flow, who are admitted to the intensive care unit (ICU). Ethics approval will be sought from each participating institution before starting enrolmentand consent will be obtained for each patient. The coordinating center will be Hospital Universitari Vall d'Hebron in Barcelona, Spain.
All consecutive patients older than 18 years with acute hypoxemic respiratory failure who need to be supported with nasal high flow (NHF) will be enrolled if they meet all the following criteria:
- Respiratory rate > 25 breaths/min
- A pulse oximetry (SpO2)<92% while receiving standard oxygen administered through a facemask at 10L/min or more.
- Pulmonary infiltrate on chest X-ray.
Patients already treated with NHF for acute respiratory failure prior to ICU admission will be enrolled if duration of NHF prior to randomization does not exceed one hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive patients older than 18 years with acute hypoxemic respiratory failure who need to be supported with nasal high flow (NHF) will be considered for inclusion.
- •Criteria for initiation of NHF if they had a respiratory rate > 25 breaths/min and/or pulse oximetry (SpO2) < 92% while receiving standard oxygen administered through a facemask at 10 L/mn or more.
- •Patients already treated with NHF for acute respiratory failure prior to ICU admission will be enrolled if duration of NHF prior to randomization does not exceed one hour.
排除标准
- •Patients younger than 18 years old.
- •Patients with indication for immediate intubation.
- •Patients treated with NHF for more than 1h prior to randomization.
- •Patients with do-not-intubate order.
- •Patients electively intubated for diagnostic or therapeutic procedures. (fibrobronchoscopy, surgery).
- •Patients with no pulmonary infiltrates on chest X-ray
- •Patient with post-extubation AHRF.
- •Awake ECMO.
- •Pregnancy.
- •Refusal to participate or participation in another interventional study with the same primary outcome.
结局指标
主要结局
Early intubation
时间窗: 12 hours since HFNC onset
Proportion of patients who will be intubated in the first 12 hours after inclusion between the two groups
次要结局
- 90-day mortality(90 days)
- Need for tracheotomy(Through ICU length of stay, an average of 30 days)
- ICU length of stay(Through ICU length of stay, an average of 30 days)
- 28-day mortality(28 days)
- Ventilator-free days within the first 28 days(28 days since the intubation)
- Hospital length of stay(Through hospital length of stay, an average of 45 days)
- Intubation rate(Through ICU length of stay, an average of 30 days)
- ICU mortality(Through ICU length of stay, an average of 30 days)
- Hospital mortality(Through hospital length of stay, an average of 45 days)
- Days free of respiratory support within the first 28 days(28 days since randomization)
- Use of rescue treatments(Through ICU length of stay, an average of 30 days)
- Rate of complications during tracheal intubation(Through ICU length of stay, an average of 30 days)