The Effect of High Frequency Oscillation on Biological Markers of Ventilator Induced Lung Injury (VILI): Nested Translational Biology Sub-Study of the OSCILLATE Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Serum concentration of known biomarkers associated with VILI and biotrauma
研究概览
简要总结
Although mechanical ventilation is life saving, it is associated with a number of severe complications collectively referred to as ventilator induced lung injury (VILI). VILI contributes to the high morbidity and mortality associated with the acute respiratory distress syndrome (ARDS). Within the context of a randomized study evaluating the feasibility of conducting a study comparing high frequency oscillation to conventional lung protective ventilation in early severe ARDS, we are evaluating the effect of both ventilator strategies on biological markers of VILI.
详细描述
Specific objectives:
To measure known biomarkers conventionally associated with VILI and biotrauma To measure potential novel biomarkers of VILI and biotrauma To identify the best time point for biomarker measurement To collect and store samples for differential expression and genomic analysis
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Informed consent previously obtained for enrollment in the OSCILLATE study:
- •Acute onset of respiratory failure
- •Endotracheal intubation or tracheostomy
- •Hypoxemia (P:F <200 mmHg)
- •Bilateral alveolar consolidation
排除标准
- •Refusal of consent to participate in this biomarkers substudy
结局指标
主要结局
Serum concentration of known biomarkers associated with VILI and biotrauma
时间窗: Baseline, after standardization, 6-10 hours after randomization, 12-16 hours after randomization, 24-30 hours after randomization, 72-76 hours after randomization, and every 3 subsequent days until death, discharge, or completion of the study at 28 days
次要结局
- Serum concentration of tissue and cell specific markers that are potential novel biomarkers associated with VILI and biotrauma(Baseline, after standardization, 6-10 hours after randomization, 12-16 hours after randomization, 24-30 hours after randomization, 72-76 hours after randomization, and every 3 subsequent days until death, discharge, or completion of the study at 28 days)