Transbronchial Lung Biopsy Versus Transbronchial Lung Cryobiopsy in Critically Ill Patients With Undiagnosed Acute Hypoxemic Respiratory Failure: a Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Diagnostic yield
研究概览
简要总结
In patients with acute hypoxemic respiratory failure whose diagnosis is not established after initial evaluation, obtaining a histopathological diagnosis may improve the patients' prognosis. In our previous retrospective-controlled study, transbronchial lung cryobiopsy (TBLC) can lead to an increased chance of establishing a diagnosis compared with transbronchial lung biopsy (TBLB), with an acceptable safety profile. Therefore, further prospective randomized controlled studies exploring whether TBLC leads to improved prognosis for such patients are warranted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Diagnosis of acute hypoxemic respiratory failure
- •Routine assessments [including bronchoscopy, bronchoalveolar lavage fluid cytology and pathogenic (including pathogenic mNGS) tests, blood tests, etc.] do not clarify the etiology, or there is an unexplained disease process
- •Imaging shows a multi-lobar segmental distribution of ground glass opacity with or without consolidations
- •Patients' families agreed to participate in the study and signed an informed consent form
排除标准
- •Significant hemodynamic instability
- •Uncorrectable coagulopathy
- •Severe pulmonary hypertension
- •Acute coronary syndrome
- •Intermediate-high-risk acute pulmonary embolism
- •Acute phase of stroke
- •Severe emphysema
- •Aortic dissection and massive gastrointestinal bleeding
- •Other conditions that are not suitable for participation in the clinical trial
研究组 & 干预措施
Transbronchial lung cryobiopsy
干预措施: Transbronchial lung cryobiopsy (Procedure)
Transbronchial lung biopsy
干预措施: Transbronchial lung biopsy (Procedure)
结局指标
主要结局
Diagnostic yield
时间窗: 7 days after procedure
The diagnostic yield of each procedure.
次要结局
- Hospital stay(up to 60 days)
- Mortality(28 and 60 days)
- Organ support(up to 60 days)
- Incidence of procedure related adverse events(3 days after procedure)
研究者
Shiyao Wang
Attending Physician
China-Japan Friendship Hospital