NCT03581474终止不适用
Evaluation of a Bronchoalveolar Lavage Procedure With a Flexible Disposable Bronchoscope, Ambu aScope 3 Large in Patients in an Intensive Care Unit Setting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Ambu A/S
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Improvement in Oxygenation (PaO2/FiO2 Ratio) After a BAL Treatment
研究概览
简要总结
An Investigation to determine the single-use scope's ability to suction secretion from the lungs to resolve the collapse of the lung.
详细描述
The purpose of this investigation it to determine the single-use scope's ability to suction secretion from the lungs to resolve the collapse of the lung. The hypothesis is that aScope 3 Large is able to manage the secretion and thereby facilitating the resolution of secretion in the lung.
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
- •Patients ≥18 years
- •Clinical indication and eligible for a BAL procedure, as judged by the investigator
- •Patients being admitted in the ICU at the investigational centre
- •Provision of signed IC by subject, or subject's legal representative e.g. next of kin
排除标准
- •Patients where BAL treatment cannot be clinically justified, judged by the investigator
- •ETT >7 mm and ≤8.5 mm in diameter
- •Participating in other interventional clinical investigations or have previously participated in this investigation
结局指标
主要结局
Improvement in Oxygenation (PaO2/FiO2 Ratio) After a BAL Treatment
时间窗: 4 hours after procedure
Resolution of atelectasis measured by improvement in oxygenation after a bronchoscopic procedure (bronchoalveolar lavage treatment). PaO2/FiO2 ratio will be compared between baseline and 4 hourst post the BAL procedure.
次要结局
未报告次要终点
研究者
研究点 (2)
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