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

NCT ID: NCT05631132

Last Updated: 2023-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-04

Study Completion Date

2024-06-01

Brief Summary

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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

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Conditions

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Chronic Obstructive Pulmonary Disease Interstitial Lung Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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BAL + NIV

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.

Group Type EXPERIMENTAL

BAL + PAP

Intervention Type PROCEDURE

May noninvasive mechanical ventilation (NIV) and/or continuous positive airway pressure (CPAP) increase the bronchoalveolar lavage (BAL) salvage in patients with pulmonary diseases?

BAL + CPAP

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.

Group Type EXPERIMENTAL

BAL + PAP

Intervention Type PROCEDURE

May noninvasive mechanical ventilation (NIV) and/or continuous positive airway pressure (CPAP) increase the bronchoalveolar lavage (BAL) salvage in patients with pulmonary diseases?

Interventions

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BAL + PAP

May noninvasive mechanical ventilation (NIV) and/or continuous positive airway pressure (CPAP) increase the bronchoalveolar lavage (BAL) salvage in patients with pulmonary diseases?

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Silesia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pulmunology Department

Katowice, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Anna Danel, Medical Doctor

Role: CONTACT

+48 570 934 340

Facility Contacts

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Anna Danel

Role: primary

References

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Danel A, Tobiczyk E, Warcholinski A, Trzaska-Sobczak M, Swinarew A, Brozek G, Trejnowska E, Batura-Gabryel H, Jedynak A, Scala R, Barczyk A, Cofta S, Skoczynski S. May noninvasive mechanical ventilation and/ or continuous positive airway pressure increase the bronchoalveolar lavage salvage in patients with pulmonary diseases? Randomized clinical trial - Study protocol. Adv Med Sci. 2023 Sep;68(2):482-490. doi: 10.1016/j.advms.2023.10.009. Epub 2023 Nov 7.

Reference Type DERIVED
PMID: 37945441 (View on PubMed)

Other Identifiers

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2203

Identifier Type: -

Identifier Source: org_study_id

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