Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-03 @ 2:57 PM
Study NCT ID:
NCT02346305
Status:
UNKNOWN
Last Update Posted:
2023-03-29
First Post:
2015-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort of Respiratory Failure Patients Treated for the First Time With Non-Invasive Ventilation at Home
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2015-01-09', 'studyFirstSubmitQcDate': '2015-01-20', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical data leading to NIV device prescription', 'timeFrame': 'Day 1', 'description': 'Age, blood gases, BMI, etiology, pulmonary function,comorbidities'}], 'secondaryOutcomes': [{'measure': 'Change in blood gases', 'timeFrame': '4 months, 1 year and 2 years after inclusion'}, {'measure': 'Change in the possible comorbidities', 'timeFrame': '4 months, 1 year and 2 years after inclusion'}, {'measure': 'Treatment compliance', 'timeFrame': 'Initiation of treatment to 4 months'}, {'measure': 'Treatment compliance', 'timeFrame': '4 months to 1 year'}, {'measure': 'Treatment compliance', 'timeFrame': '1 year to 2 years (end of study)'}, {'measure': 'Hospitalizations', 'timeFrame': '4 months', 'description': 'During the study period all hospitalizations will be notify'}, {'measure': 'Hospitalizations', 'timeFrame': '1 year', 'description': 'During the study period all hospitalizations will be notify'}, {'measure': 'Hospitalizations', 'timeFrame': '2 years', 'description': 'During the study period all hospitalizations will be notify'}, {'measure': 'Survival rate', 'timeFrame': '4 months'}, {'measure': 'Survival rate', 'timeFrame': '1 year'}, {'measure': 'Survival rate', 'timeFrame': '2 years'}]}, 'conditionsModule': {'conditions': ['Respiratory Insufficiency']}, 'descriptionModule': {'briefSummary': "The effectiveness of NIV is clearly demonstrated but no recent studies describe the prescription based on clinical data and the conditions of using NIV at home according the various respiratory diseases.\n\nThe investigators' purpose is that a better knowledge of NIV practices could improve both the quality to support patients at home and the efficacy of the treatment.\n\nThe main objective of this study is to analyze the clinical data justifying the prescription of NIV advice according respiratory disease. The secondary objectives are to study comorbidities, treatment failures, survival rate during the study period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with respiratoy insufficiency', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No previous experience with domiciliary non-invasive ventilation\n* Adult patients, ≥ 18 years of age\n* Without tracheotomy\n* No evolutive cancer\n* No significant psychiatric disease\n* Possible medical monitoring\n\nExclusion Criteria:\n\n* Evolutive cancer\n* Inability to understand rationale and/or consent form for study'}, 'identificationModule': {'nctId': 'NCT02346305', 'briefTitle': 'Cohort of Respiratory Failure Patients Treated for the First Time With Non-Invasive Ventilation at Home', 'organization': {'class': 'OTHER', 'fullName': 'Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche'}, 'officialTitle': 'Multicenter Prospective and Observational Cohort of Respiratory Failure Patients Treated for the First Time With Non-invasive Ventilation (NIV) at Home', 'orgStudyIdInfo': {'id': '2014 - NIV - 14734'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Non-invasive ventilation', 'type': 'DEVICE', 'description': 'Home NIV installation'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric GAGNADOUX, Pr', 'role': 'CONTACT'}], 'facility': "CHU d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Besançon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric CLAUDE, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Cannes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe PERRIN, MD', 'role': 'CONTACT'}], 'facility': 'CH de Cannes', 'geoPoint': {'lat': 43.55135, 'lon': 7.01275}}, {'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Claudio RABEC, MD', 'role': 'CONTACT', 'email': 'claudio.rabec@chu-dijon.fr'}], 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Garches', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hélène PRIGENT, MD', 'role': 'CONTACT'}], 'facility': 'Garches', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'city': 'Grenoble', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Louis PEPIN, Pr', 'role': 'CONTACT'}], 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'La Réunion', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ziad RIDA, MD', 'role': 'CONTACT'}], 'facility': 'CHD de la Réunion', 'geoPoint': {'lat': 44.29707, 'lon': 0.11776}}, {'city': 'Lille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne MALLART, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Limoges', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Boris MELLONI, Pr', 'role': 'CONTACT'}], 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Nancy', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'François CHABOT, Pr', 'role': 'CONTACT'}], 'facility': 'CHU de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jésus GONZALEZ, MD', 'role': 'CONTACT'}], 'facility': 'AP-HP Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Franck LAVERGNE, MD', 'role': 'CONTACT'}], 'facility': 'Hôpital Edouard Rist', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antoine CUVELIER, Pr', 'role': 'CONTACT'}], 'facility': 'CHU de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Rouen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-François MUIR, Pr', 'role': 'CONTACT'}], 'facility': 'CHU de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Strasbourg', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romain KESSLER, Pr', 'role': 'CONTACT'}], 'facility': 'CHU de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sandrine PONTIER, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Vantoux', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre CERVANTES, MD', 'role': 'CONTACT'}], 'facility': 'Hôpital Robert Schuman', 'geoPoint': {'lat': 49.12945, 'lon': 6.23201}}], 'centralContacts': [{'name': 'Didier FORET', 'role': 'CONTACT', 'email': 'antadir@antadir.com', 'phone': '33 (1) 56 81 40 60'}], 'overallOfficials': [{'name': 'Claudio RABEC, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire Dijon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}