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

• Sponsor: Medical University of Silesia (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05631132
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 18
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Recovery of BAL Fluid	Procedure: BAL + NIV	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?
• Anticipated Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: BAL + NIV	Procedure: BAL + NIV; May noninvasive mechanical ventilation (NIV) and/or continuous positive airway pressure (CPAP) increase the bronchoalveolar lavage (BAL) salvage in patients with pulmonary diseases?
Other: BAL without NIV	Procedure: BAL + NIV; May noninvasive mechanical ventilation (NIV) and/or continuous positive airway pressure (CPAP) increase the bronchoalveolar lavage (BAL) salvage in patients with pulmonary diseases?

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pulmunology Department	Katowice		Poland	40-635

Sponsors and Collaborators

• Medical University of Silesia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Silesia
• ClinicalTrials.gov Identifier: NCT05631132
• Other Study ID Numbers: 2203
• First Posted: Nov 30, 2022
• Last Update Posted: Nov 30, 2022
• Last Verified: Nov 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Medical University of Silesia: BAL, NIV, CPAP, COPD, interstinal lungs disease, bronchoskopy
• Additional relevant MeSH terms: Lung Diseases

Study Results

No Results Posted as of Nov 30, 2022