Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT05631132
Status:
UNKNOWN
Last Update Posted:
2023-09-07
First Post:
2022-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-04', 'studyFirstSubmitDate': '2022-11-18', 'studyFirstSubmitQcDate': '2022-11-18', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'May noninvasive mechanical ventilation (NIV) and/or continuous positive airway pressure (CPAP) increase the bronchoalveolar lavage (BAL) salvage in patients with pulmonary diseases?', 'timeFrame': '3 years', 'description': 'Comparison of fluid recovery with BAL with and without NIV connection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bronchoalveolar Lavage', 'Noninvasive Mechanical Ventilation', 'Continuous Positive Airway Pressure', 'Bronchoscopy'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Interstitial Lung Disease']}, 'referencesModule': {'references': [{'pmid': '37945441', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with diagnosed stable COPD (Stages 1-3) - experimental group; Patients with interstitial lung disease - experimental group\n2. Former and current smokers with normal lung function - potential control group 1;\n3. Never-smokers with normal lung ventilation - potential control group 2.\n\nExclusion Criteria:\n\n1. No written, informed consent to participate in the research project.\n2. Severe respiratory failure (SaO2 \\< 90%)\n3. The patient qualified for home oxygen treatment or home mechanical ventilation\n4. Severe heart failure (NYHA class IV)\n5. COPD mMRC IV\n6. Myocardial infarction in the last two weeks or unstable angina\n7. Severe, particularly ventricular arrhythmias\n8. Platelet count \\< 20,000/ul\n9. INR \\> 2 or APPT \\> 36 sec\n10. Very severe obstruction: forced expiratory volume in 1 second (FEV1) \\< 30% of predicted.'}, 'identificationModule': {'nctId': 'NCT05631132', 'acronym': 'PAP+BAL', 'briefTitle': 'May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Silesia'}, 'officialTitle': 'May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?', 'orgStudyIdInfo': {'id': '2203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAL + NIV', '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.', 'interventionNames': ['Procedure: BAL + PAP']}, {'type': 'EXPERIMENTAL', 'label': 'BAL + CPAP', '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.', 'interventionNames': ['Procedure: BAL + PAP']}], 'interventions': [{'name': 'BAL + PAP', 'type': 'PROCEDURE', 'description': 'May noninvasive mechanical ventilation (NIV) and/or continuous positive airway pressure (CPAP) increase the bronchoalveolar lavage (BAL) salvage in patients with pulmonary diseases?', 'armGroupLabels': ['BAL + CPAP', 'BAL + NIV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40-635', 'city': 'Katowice', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Anna Danel', 'role': 'CONTACT', 'email': 's71696@365.sum.edu.pl'}], 'facility': 'Pulmunology Department', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}], 'centralContacts': [{'name': 'Anna Danel, Medical Doctor', 'role': 'CONTACT', 'email': 's71696@365.sum.edu.pl', 'phone': '+48 570 934 340'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Silesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}