NCT00465374Unknown3 期
A Validation/Interventional Study on Stress Index in Predicting Mechanical Stress in ARDS Patients
University of Turin, Italy1 个研究点 分布在 1 个国家开始时间: 2002年10月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 试验地点
- 1
- 主要终点
- reduction of pulmonary inflammatory mediators
研究概览
简要总结
30% of ARDS patients ventilated according to NIH protocol presents CT scan evidence of hyperinflation. Functional analysis of pressure-time curve (Stress Index=SI) has been shown to identify this condition in experimental settings. We tested the hypothesis that the SI is an accurate predictor of mechanical stress due to overdistention in ARDS patients.
详细描述
The study presents two parts : a preliminary validation study and a clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Diagnosis of ARDS based on American-European Consensus Conference criteria
排除标准
- •>3 days since ARDS criteria were met and mechanical ventilation was started
- •History of ventricular fibrillation or tachyarrhythmia, unstable angina or myocardial infarction within preceding month
- •Pre-existing chronic obstructive pulmonary disease
- •Major chest wall abnormalities
- •Chest tube with persistent air leak
- •Abdominal distension
- •Body mass index >30
- •Pregnancy
- •Known intracranial abnormality
- •Enrollment in another interventional study
结局指标
主要结局
reduction of pulmonary inflammatory mediators
次要结局
未报告次要终点
研究者
研究点 (1)
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