search
Back to results

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)

Primary Purpose

Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
BAL + PAP
Sponsored by
Medical University of Silesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease focused on measuring Bronchoalveolar Lavage, Noninvasive Mechanical Ventilation, Continuous Positive Airway Pressure, Bronchoscopy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Pulmunology DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BAL + NIV

BAL + CPAP

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 18, 2022
Last Updated
September 4, 2023
Sponsor
Medical University of Silesia
search

1. Study Identification

Unique Protocol Identification Number
NCT05631132
Brief Title
May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?
Acronym
PAP+BAL
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?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Silesia

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease
Keywords
Bronchoalveolar Lavage, Noninvasive Mechanical Ventilation, Continuous Positive Airway Pressure, Bronchoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BAL + NIV
Arm Type
Experimental
Arm 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.
Arm Title
BAL + CPAP
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
BAL + PAP
Intervention Description
May noninvasive mechanical ventilation (NIV) and/or continuous positive airway pressure (CPAP) increase the bronchoalveolar lavage (BAL) salvage in patients with pulmonary diseases?
Primary Outcome Measure Information:
Title
May noninvasive mechanical ventilation (NIV) and/or continuous positive airway pressure (CPAP) increase the bronchoalveolar lavage (BAL) salvage in patients with pulmonary diseases?
Description
Comparison of fluid recovery with BAL with and without NIV connection
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Danel, Medical Doctor
Phone
+48 570 934 340
Email
s71696@365.sum.edu.pl
Facility Information:
Facility Name
Pulmunology Department
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Danel
Email
s71696@365.sum.edu.pl

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs