NCT05631132

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

September 7, 2023

Status Verified

November 1, 2022

Enrollment Period

1.7 years

First QC Date

November 18, 2022

Last Update Submit

September 4, 2023

Conditions

Chronic Obstructive Pulmonary DiseaseInterstitial Lung Disease

Keywords

Bronchoalveolar LavageNoninvasive Mechanical VentilationContinuous Positive Airway PressureBronchoscopy

Outcome Measures

Primary Outcomes (1)

  • 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

    3 years

Study Arms (2)

BAL + NIV

EXPERIMENTAL

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.

Procedure: BAL + PAP

BAL + CPAP

EXPERIMENTAL

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.

Procedure: BAL + PAP

Interventions

BAL + PAPPROCEDURE

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

BAL + CPAPBAL + NIV

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmunology Department

Katowice, 40-635, Poland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37945441DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Anna Danel, Medical Doctor

CONTACT

+48 570 934 340s71696@365.sum.edu.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2022

First Posted

November 30, 2022

Study Start

September 4, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

September 7, 2023

Record last verified: 2022-11

Locations

PL(1)