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

Medical University of Silesia

Status: Enrolling

Conditions: Chronic Obstructive Pulmonary Disease; Interstitial Lung Disease

Treatments: Procedure: BAL + PAP

Study type: Interventional

Funder types: Other

Identifiers

NCT05631132

2203

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with diagnosed stable COPD (Stages 1-3) - experimental group; Patients with interstitial lung disease - experimental group
2. Former and current smokers with normal lung function - potential control group 1;
3. Never-smokers with normal lung ventilation - potential control group 2.

Exclusion criteria

1. No written, informed consent to participate in the research project.
2. Severe respiratory failure (SaO2 < 90%)
3. The patient qualified for home oxygen treatment or home mechanical ventilation
4. Severe heart failure (NYHA class IV)
5. COPD mMRC IV
6. Myocardial infarction in the last two weeks or unstable angina
7. Severe, particularly ventricular arrhythmias
8. Platelet count < 20,000/ul
9. INR > 2 or APPT > 36 sec
10. Very severe obstruction: forced expiratory volume in 1 second (FEV1) < 30% of predicted.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

BAL + NIV

Experimental group

Description:

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.

Treatment:

Procedure: BAL + PAP

BAL + CPAP

Experimental group

Description:

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.

Treatment:

Procedure: BAL + PAP