Inhaled Hypertonic Saline for the Treatment of Acute Lung Injury
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Dynamic Compliance of the Respiratory System
研究概览
简要总结
To determine if an inhaled hypertonic saline solution has any effect on lung function in patients with acute respiratory distress syndrome (ARDS).
详细描述
Hypertonic Saline (HS) aerosols have proven efficacious mucolytics in patient with cystic fibrosis and are well tolerated in that population. Safety concerns in mechanically ventilated patients with ARDS center primarily on HS's effects on lung water distribution (intra vs. extra alveolar) and on airway reactivity. For that reason we plan a small feasibility trial with narrowly focused physiologic endpoints, namely to measure the effects of a single 5ml dose of 7% Saline aerosol on blood gas tensions, hemodynamics and the static and dynamic properties of the relaxed respiratory system. This narrowly scoped study is to lay the foundation for a larger multicenter intervention trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study participants will include consenting adult patients (age > 18), who had been intubated and mechanically ventilated for <72 hours and meet international consensus criteria for ARDS.
排除标准
- 未提供
研究组 & 干预措施
Hypertonic Saline Aerosol
a single 5ml dose of 7% Saline aerosol
干预措施: Hypertonic Saline Aerosol (Drug)
结局指标
主要结局
Dynamic Compliance of the Respiratory System
时间窗: Between 5 & 10 minutes before aerosol delivery and 5 to 10 minutes after completion of the aerosol delivery
Changes in the static and dynamic properties of the respiratory system are surrogate markers of a change in airway tone and/or of the amount and distribution of alveolar edema
次要结局
- Patient-Ventilator Interactions(5 minutes before aersosol delivery, during the 15 minutes while aerosol is being delivered and 5 minutes after completion of the aerosol delivery)
研究者
Richard A. Oeckler, M.D., Ph.D.
Assistant Professor of Medicine and Physiology
Mayo Clinic