May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- May noninvasive mechanical ventilation (NIV) and/or continuous positive airway pressure (CPAP) increase the bronchoalveolar lavage (BAL) salvage in patients with pulmonary diseases?
研究概览
简要总结
The objective of our project is to find procedures and/or parameters to predict the diagnostic recovery (≥ 60% of the administered fluid volume) of bronchoalveolar lavage (BAL) fluid before bronchoscopy and to assess the impact of using non-invasive mechanical ventilation (NMV) or continuous positive airway pressure (CPAP) to achieve diagnostic recovery in patients with chronic obstructive pulmonary disease (COPD) and interstinal lungs disease for whom BAL performed during ordinary bronchoscopy turns out to be non-diagnostic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosed stable COPD (Stages 1-3) - experimental group; Patients with interstitial lung disease - experimental group
- •Former and current smokers with normal lung function - potential control group 1;
- •Never-smokers with normal lung ventilation - potential control group 2.
排除标准
- •No written, informed consent to participate in the research project.
- •Severe respiratory failure (SaO2 < 90%)
- •The patient qualified for home oxygen treatment or home mechanical ventilation
- •Severe heart failure (NYHA class IV)
- •COPD mMRC IV
- •Myocardial infarction in the last two weeks or unstable angina
- •Severe, particularly ventricular arrhythmias
- •Platelet count < 20,000/ul
- •INR > 2 or APPT > 36 sec
- •Very severe obstruction: forced expiratory volume in 1 second (FEV1) < 30% of predicted.
研究组 & 干预措施
BAL + NIV
Qualification for a specific type of ventilation (NIV or CPAP) will be carried out in a randomized manner by a specially created online platform. The procedure will be performed subsequently in the same segment of the opposite lung. Once the test is finished, the volume of BAL fluid that has been recovered will be measured.
干预措施: BAL + PAP (Procedure)
BAL + CPAP
Qualification for a specific type of ventilation (NIV or CPAP) will be carried out in a randomized manner by a specially created online platform. The procedure will be performed subsequently in the same segment of the opposite lung. Once the test is finished, the volume of BAL fluid that has been recovered will be measured.
干预措施: BAL + PAP (Procedure)
结局指标
主要结局
May noninvasive mechanical ventilation (NIV) and/or continuous positive airway pressure (CPAP) increase the bronchoalveolar lavage (BAL) salvage in patients with pulmonary diseases?
时间窗: 3 years
Comparison of fluid recovery with BAL with and without NIV connection
次要结局
未报告次要终点