跳至主要内容
临床试验/NCT05631132
NCT05631132招募中不适用

May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?

Medical University of Silesia2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年9月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
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

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.

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验