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

Not Applicable

Recruiting

• Conditions: Interstitial Lung Disease; Chronic Obstructive Pulmonary Disease
• Interventions: Procedure: BAL + PAP

• Registration Number: NCT05631132
• Lead Sponsor: Medical University of Silesia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-04
• Status Verified: 2022-11
• Study First Submitted: 2022-11-18
• Study First Submitted QC: 2022-11-18
• Study First Posted: 2022-11-30
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-07
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BAL + NIV	BAL + PAP	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.
BAL + CPAP	BAL + PAP	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.

Primary Outcome Measures

Name	Time	Method
May noninvasive mechanical ventilation (NIV) and/or continuous positive airway pressure (CPAP) increase the bronchoalveolar lavage (BAL) salvage in patients with pulmonary diseases?	3 years	Comparison of fluid recovery with BAL with and without NIV connection

Trial Locations

Locations (1)

Pulmunology Department; 🇵🇱 Katowice, Poland