Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS): A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Duration in Prone Position
研究概览
简要总结
Prone positioning is one of the few therapies known to improve mortality in ARDS. Traditionally, patients are proned for 16 hours per 24 hour period. Some retrospective data suggests improvement may persist beyond 16 hours. We aim to perform a pilot study comparing traditional prone positioning to prolonged prone positioning in patients with COVID-induced ARDS.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive COVID test Endotracheal Intubation P:F <150 within 1hours of inclusion on at least 60% FiO2, 10cmH20 PEEP Treating physician plans to implement prone positioning imminently Housed in the UAB MICU.
排除标准
- •Pre-existing treatment limitation (e.g. DNR order) Prisoner Pregnant Female Children (<18 years old) Respiratory Failure felt to be caused primarily by something other than COVID-19 Mechanical ventilation for >48 hours prior to initiation of prone positioning Contraindication to proning Physician discretion
研究组 & 干预措施
Prolonged Proning Arm
Patients will receive 24 hours in the prone position followed by 8 hours in the supine position for the duration of the study
干预措施: Prolonged Proned Positioning (Other)
Traditional Proning Arm
Patients will receive standard 16 hour prone positioning followed by 8 hours in the supine position for the duration of the study
干预措施: Traditional Proning Arm (Other)
结局指标
主要结局
Duration in Prone Position
时间窗: 96 hours
Time spent in the prone position of hours eligible for prone positioning
次要结局
- Pressure Ulcers(End of supine session on day 4)
- Unplanned Extubations(End of supine session on day 4)
- Line Displacement(End of supine session on day 4)
- Vent Free Days(30 days)
- Change in P:F Ratio(End of supine session on day 4)
- Rescue Interventions(96 hours)
- ICU Free Days(30 days)
- Change in Drive Pressure(End of supine session on day 4)
- Tracheostomy(30 days)
- Mortality(30 days)
- S:F Ratio(96 hours)
研究者
David Page
Assistant Professor
University of Alabama at Birmingham