Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-25 @ 1:15 PM
Study NCT ID:
NCT04212559
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2019-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hemodynamic Effects of Negative Pressure Ventilation in Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-13', 'studyFirstSubmitDate': '2019-11-16', 'studyFirstSubmitQcDate': '2019-12-25', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CO (cardiac output)', 'timeFrame': '20 minutes', 'description': 'Change of Cardiac output before and after NPV treatment'}, {'measure': 'SV (stroke volume)', 'timeFrame': '20 minutes', 'description': 'Change of stroke volume before and after NPV treatment'}], 'secondaryOutcomes': [{'measure': 'SpO2', 'timeFrame': '20 minutes', 'description': 'Change of oxygen saturation before and after NPV treatment'}, {'measure': 'RR (respiratory rate)', 'timeFrame': '20 minutes', 'description': 'Change of respiratory rate before and after NPV treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'Negative pressure ventilation (NPV) is a non-invasive ventilation mode which provide better lung expansion. The major complication of NPV is decrease blood pressure and affects the hemodynamics. The effects of NPV on chronic obstructive pulmonary disease (COPD) patients with pulmonary rehabilitation program remains unknown.', 'detailedDescription': 'Both of NPV or positive pressure ventilation (PPV) has impact of hemodynamics. NPV with cuirass ventilator increases venous return and leads to ventricular filling and increases cardiac output (CO); In contrast to NPV, the effect of PPV in most situations is a decreased venous return and leads to decreased CO. NPV improving ventilation and work of breathing in patients with chronic obstructive pulmonary disease (COPD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with COPD who received pulmonary rehabilitation program with NPV treatment\n\nExclusion Criteria:\n\n* Recent exacerbation within 3-months\n* Existing of tracheostomy\n* Absence of NPV used\n* Required of oxygen supplement during NPV\n* Diagnosed of neuromuscular disease'}, 'identificationModule': {'nctId': 'NCT04212559', 'briefTitle': 'Hemodynamic Effects of Negative Pressure Ventilation in Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Fu Jen Catholic University'}, 'officialTitle': 'Hemodynamic Effects of Negative Pressure Ventilation in Chronic Obstructive Pulmonary Disease Assessed Using Non-Invasive Electrical Cardiometry', 'orgStudyIdInfo': {'id': 'C107137'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NPV group', 'description': 'Patients who had treated in pulmonary rehabilitation unit with NPV', 'interventionNames': ['Other: Received negative pressure ventilation']}], 'interventions': [{'name': 'Received negative pressure ventilation', 'type': 'OTHER', 'description': 'Patients who received a negative pressure during inspiratory phase.', 'armGroupLabels': ['NPV group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24352', 'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Fu Jen Catholic University Hospital, Fu Jen Catholic University', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fu Jen Catholic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Respiratory Therapist', 'investigatorFullName': 'Ke-Yun, Chao', 'investigatorAffiliation': 'Fu Jen Catholic University'}}}}