Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-30 @ 3:16 AM
Study NCT ID:
NCT00428857
Status:
COMPLETED
Last Update Posted:
2011-02-24
First Post:
2007-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Noninvasive Ventilatory Support After Lung Surgery in COPD Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063087', 'term': 'Noninvasive Ventilation'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-23', 'studyFirstSubmitDate': '2007-01-29', 'studyFirstSubmitQcDate': '2007-01-29', 'lastUpdatePostDateStruct': {'date': '2011-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['COPD', 'Post Pulmonary Resection']}, 'descriptionModule': {'briefSummary': 'Rationale: respiratory complications are the most frequent complications following lung resection and represent a noticeable cause of mortality. Benefits from non-invasive ventilation (NIV) in acute respiratory failure are now clearly demonstrated. The use of preventive NIV after lung resection, in the absence of acute respiratory failure and/or hypercarbia, could be justified by the physiological benefits expected. The goal of this study is to assess the efficacy of post-operative NIV in moderate-to-severe COPD, for prevention of respiratory complications.\n\nMaterial and Methods: This is a prospective randomised multicenter trial with an open parallel design in moderate-t-o-severe COPD patients hospitalised in thoracic surgery for lung resection.\n\nExpected results: This study will determine whether post-operative NIV decreases the incidence of acute respiratory events (acute respiratory failure) and whether some subgroups of patients benefit more from this strategy.\n\nConclusion: This study should help evaluating the utility of post-operative NIV after lung resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with COPD (FEV1 pre-operative \\<80% and FEV1/CV\\<70%)\n* Patients undergoig pulmonary resection\n* Informed consent\n\nExclusion Criteria:\n\n* Apnea syndrom and chronic noninvasive support\n* Post-operative extrarespiratory organ failure\n* Inhability to follow study protocole\n* Absence of medical coverage'}, 'identificationModule': {'nctId': 'NCT00428857', 'acronym': 'POPVNI', 'briefTitle': 'Noninvasive Ventilatory Support After Lung Surgery in COPD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Noninvasive Ventilatory Support After Lung Surgery to Prevent Pulmonary Complications in COPD Patients', 'orgStudyIdInfo': {'id': 'P070501'}}, 'armsInterventionsModule': {'interventions': [{'name': 'non invasive ventilation', 'type': 'PROCEDURE', 'description': 'non invasive ventilation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21034', 'city': 'Dijon', 'state': 'Dijon', 'country': 'France', 'facility': 'Hopital Du Bocage', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '75015', 'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'HEGP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Pontoise', 'state': 'Pontoise', 'country': 'France', 'facility': 'hopital de Pontoise', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}, {'city': 'Strasbourg', 'state': 'Strasbourg', 'country': 'France', 'facility': 'CHU strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '75004', 'city': 'Paris', 'country': 'France', 'facility': 'Hotel Dieu', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Mutualiste Montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31049', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Larrey', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'christine lorut, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP'}, {'name': 'antoine rabbat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Yannick VACHER', 'oldOrganization': 'Department of Clinical Research of developpement'}}}}