OptiMal pronE Position LEnghT in Patients With acuTE Respiratory Distress Syndrome Due to COVID-19.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Ventilator-free days at 60 days
研究概览
简要总结
The OMELETTE study is a randomised, controlled, unicentric, open-label study to prove the noninferiority of reduced prone position (PP) sessions (more tan 16 hours) versus prolonged PP (48 hours).
详细描述
This is a non-comercial, investigator-driven clinical study developed in a single critical care unit.
The study is coordinated by the main investigator from Hospital Universitario 12 de Octubre in Madrid; The sponsorship is performed by Dr. Ignacio Sáez (Hospital Universitario 12 de Octubre).
The study was planned according to the Good Clinical Practices. Omelette study has been approved by the Ethics Committee. All participating Patients must give informed consent before any study procedure occur.
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
- None
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
- •Patient above 18 year-old.
- •Diagnosis of severe ARDS due to COVID-19 under invasive mechanical ventilation,
- •Meet criteria for PP: PaO2/FiO2 < 150 millimeters of mercury column (mmHg), PEEP ≥ 5 Centimeters of Water (cmH2O), FiO2 ≥ 60.
排除标准
- •No consent for the study.
- •PP contraindicated (( elevated intracranial pressure, massive hemoptysis, recent tracheal surgery or sternotomy, unstable hemodynamic status, recent pacemaker implantation, severe facial laceration, open abdominal wound, spine, femur or pelvis fracture or pregnancy).
研究组 & 干预措施
Control group
48 hours of PP
Experimental group
Anytime from 16 hours when PaO2/FiO2 ≥ 150 mmHg with a FiO2 < 60%
干预措施: 16-hour PP (Other)
结局指标
主要结局
Ventilator-free days at 60 days
时间窗: 60 days
Number of days from successfully weaning to day 60
Ventilator-free days at 28 days
时间窗: 28 days
Number of days from successfully weaning to day 28
次要结局
- Survival(60 days)
- ICU and Hospital stay(Hospital admission)
- Evolution of respiratory parameters(ICU admission)
- PP complications(ICU admission)
研究者
Ignacio Saez de la Fuente
Ignacio Saez de la Fuente, MD
Hospital Universitario 12 de Octubre