PRone positioN in Patients With spontanEous ventiLation and Acute Hypoxemic respIratory FailurE
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 650
- 试验地点
- 2
- 主要终点
- Composite endpoint comprising the rate of tracheal intubation or all-cause of mortality during the first fourteen days of enrolment.
研究概览
简要总结
The proposed randomized controlled trial aims at comparing the application of the prone position in spontaneously breathing patients with acute hypoxemic respiratory failure from any cause versus standard treatment on the rate of invasive mechanical ventilation or all-cause of mortality. The secondary endpoints will include time to tracheal intubation and effects of awake proning on the oxygenation parameters, dyspnea sensation, complications, and tolerance. Other endpoints are ventilation free-days at 28 days, duration of invasive ventilation, length of ICU and hospital stay, ICU and hospital mortality, and 28, 60, and 90-day mortality.
详细描述
The investigators intend to recruit acute hypoxemic respiratory failure patients with a respiratory rate of more than 25 breaths per minute, SpO2 < 94% and FiO2 of at least 40% or more by either Venturi facemask, HFNC, or NIV/CPAP and, absence of decompensated respiratory acidosis during two years. Currently, the investigators expect about 35 centers to participate in the trial.
Demographic data and clinical characteristics on screened patients, regardless of enrolment criteria match, will be recorded (registry). The investigators will randomize 650 patients admitted to the participating centers' intensive care units and expect each participating center to randomize at least 25 patients who meet all inclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •>18 years
- •Acute respiratory failure from any cause
- •Admitted to a participating ICU
- •Written informed consent
排除标准
- •Presence of any contraindication to prone position (APPENDIX i)
- •The patient meets the criteria for intubation (see item 7.2.3)
- •Participating in other interventional studies with the same primary outcome
- •Receiving comfort care only
- •Pregnancy
结局指标
主要结局
Composite endpoint comprising the rate of tracheal intubation or all-cause of mortality during the first fourteen days of enrolment.
时间窗: 14 days
次要结局
- Intubation among survivors at day 24(24 days)
- Respiratory rate(4 hours)
- Duration of invasive mechanical ventilation(90 days)
- Effects on oxygenation defined by the SpO2(4 hours)
- Ventilation-free days (VFD) at 28 days from ICU admission,(28 days)
- ICU-free days and hospital-free days(90 days)
- Days under the oxygen support device(28 days)
- Dyspnea(4 hours)
- Time to tracheal intubation(14 days)
- Mortality(28 and 90 days)
- Mortality at day 14(14 days)
- Rate of complications related to prone position(4 hours)
研究者
Luis Morales
Study Coordinator
Corporacion Parc Tauli