NCT02611297Unknown不适用
Cryoprobe Transbronchial Lung Biospy in Patients With Mechanical Ventilation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau6 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2013年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Adverse events related to transbronchial lung biopsy (TBLB) with cryoprobe
研究概览
简要总结
The purpose of this study is to evaluate the the diagnostic yield and safety of transbronchial lung biopsies (TBLB) with cryoprobe in patients with mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •≥18 years old
- •Patients with mechanical ventilation.
- •Patients with diffuse lung disease of unknown etiology.
- •Need for confirming/excluding a diagnosis, with therapeutical and prognosis implications.
- •Inform consent signed by family.
排除标准
- •Use of anticoagulant therapy or presence of a coagulation disorder (abnormal platelets counts, international normalized ratio > 1.5).
- •Comorbidities that could increase the risk of the TBLB.
- •Bullous emphysema.
- •Hemoptysis, pneumothorax.
- •Severe respiratory insufficiency requiring PEEP >12 cm H2O
结局指标
主要结局
Adverse events related to transbronchial lung biopsy (TBLB) with cryoprobe
时间窗: 27 months
次要结局
- Diagnostic yield of transbronchial lung biopsy (TBLB) obtained by cryoprobes(27 months)
研究者
研究点 (6)
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