Pragmatic Investigation of optimaL Oxygen Targets (PILOT) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,541
- 试验地点
- 2
- 主要终点
- Ventilator-free Days (VFDs) to Study Day 28
研究概览
简要总结
Mechanical ventilation of ICU patients universally involves titration of the fraction of inspired oxygen (FiO2) to maintain arterial oxygen saturation (SpO2). Despite decades of ICU practice, however, the optimal SpO2 target remains unknown. Current guidelines offer divergent recommendations as to the optimal SpO2 target. Therefore, we propose a 2,250-patient cluster-randomized cluster-crossover trial comparing a lower SpO2 target (90%; range 88-92%), an intermediate SpO2 target (94%; range 92-96%), and a higher SpO2 target (98%; range 96-100%) with regard to the outcome of days alive and free of invasive mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Observer bias will be minimized by use of objective endpoints collected in duplicate by [1] study personnel blinded to group assignment and [2] automated data extraction from the electronic health record.
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
- •Receiving mechanical ventilation through an endotracheal tube or tracheostomy
- •Admitted to the study ICU or admission to the study ICU from the emergency department is planned
排除标准
- •Known pregnancy or beta hCG level greater than the laboratory upper limit of normal in a patient capable of becoming pregnant
- •Known to be a prisoner
结局指标
主要结局
Ventilator-free Days (VFDs) to Study Day 28
时间窗: 28 days
Number of days alive and free from invasive mechanical ventilation between the final liberation from invasive mechanical ventilation before 28 days and study day 28. Patients who continue to receive invasive mechanical ventilation at day 28 or have died prior to day 28 will receive zero VFDs. For patients who return to invasive mechanical ventilation and are subsequently liberated from invasive mechanical ventilation prior to day 28, VFDs will be counted from final liberation from mechanical ventilation.
次要结局
- Vasopressor-free Days (Exploratory Clinical Outcome)(28 days)
- 28-day, In-hospital Mortality (Secondary Outcome)(28 days)
- Renal Replacement Therapy-free Days (Exploratory Clinical Outcome)(28 days)
- Hospital-free Days (Exploratory Clinical Outcome)(28 days)
- Acute Kidney Injury (AKI) (Exploratory Organ Function Outcome)(28 days)
- Intensive Care Unit Mortality (Exploratory Clinical Outcome)(28 days)
- Intensive Care Unit-free Days (Exploratory Clinical Outcome)(28 days)
研究者
Matthew Semler
Assistant Professor of Medicine
Vanderbilt University Medical Center