NCT05307913已完成不适用
EIT-guided PEEP Titration Versus Low PEEP/FiO2 Table for ARDS: a Multicenter, Randomized, Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 676
- 试验地点
- 1
- 主要终点
- Survival in 28 days
研究概览
简要总结
This study is a multicentric randomized controlled study.The objective of this study is to compare the prognosis of patients with ARDS between EIT-oriented individualized PEEP and traditional lower PEEP/FiO2 table-oriented PEEP strategy.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intubated, mechanically ventilated patients with diagnosis of ARDS according to ARDS Berlin standard by attending doctor
排除标准
- •Age < 18 years old and > 90 years old;
- •EIT contradictions (presence of pacemaker or automatic implantable cardioverter defibrillator);
- •Severe intracranial hypertension;
- •Pneumothorax, pneumomediastinum, subcutaneous emphysema or at high-risk for pneumothorax (e.g., pneumatocele, interstitial lung disease);
- •Unstable hemodynamic status intorerable to lung recruitment and PEEP titration, judged by an attending intensivist; (This may be a transient criterion, since patients meeting this criterion might be included later if hemodynamics improves)
- •End status of disease;
- •Patients or their families refused to participate in the study
研究组 & 干预措施
EIT-guided PEEP
Experimental
PEEP titration by EIT
干预措施: EIT-guided PEEP (Other)
Table-guided PEEP
Active Comparator
PEEP selection by the lower PEEP/FiO2 table
干预措施: Table-guided PEEP (Other)
结局指标
主要结局
Survival in 28 days
时间窗: 28 days
Survival within 28 days from randomization
次要结局
- 28-day ventilator-free days(28 days)
- Lenght of hospital stay(Maximum 6-months)
- Lenght of ICU stay(Maximum 6-months)
- Barotrauma(7 days)
- ICU survival(Maximum 6-months)
- hospital survival(Maximum 6-months)
- change of Sequential Organ Failure Assessment (SOFA) score(2 days)
研究者
研究点 (1)
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