Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT01181869
Status:
UNKNOWN
Last Update Posted:
2012-04-13
First Post:
2010-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Database of Patients Treated With Respiratory Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}], 'ancestors': [{'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '1983-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-04-12', 'studyFirstSubmitDate': '2010-08-11', 'studyFirstSubmitQcDate': '2010-08-12', 'lastUpdatePostDateStruct': {'date': '2012-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'death', 'timeFrame': '20 years', 'description': 'long term follow up of a regularly updated database'}], 'secondaryOutcomes': [{'measure': 'treatment adjustment', 'timeFrame': '20 years', 'description': 'Change of treatment from oxygen to ventilatioion or other evolution'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['respiratory failure', 'oxygen', 'sleep apnoea', 'ventilation'], 'conditions': ['Chronic Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '16162707', 'type': 'RESULT', 'citation': 'Chambellan A, Chailleux E, Similowski T; ANTADIR Observatory Group. Prognostic value of the hematocrit in patients with severe COPD receiving long-term oxygen therapy. Chest. 2005 Sep;128(3):1201-8. doi: 10.1378/chest.128.3.1201.'}, {'pmid': '12740261', 'type': 'RESULT', 'citation': 'Chailleux E, Laaban JP, Veale D. Prognostic value of nutritional depletion in patients with COPD treated by long-term oxygen therapy: data from the ANTADIR observatory. Chest. 2003 May;123(5):1460-6. doi: 10.1378/chest.123.5.1460.'}, {'pmid': '11468903', 'type': 'RESULT', 'citation': 'Chailleux E, Boffa C. [Chronic respiratory insufficiency in France]. Rev Prat. 2001 May 31;51(10):1061-5. French.'}, {'pmid': '10706500', 'type': 'RESULT', 'citation': "Veale D, Chailleux E, Hoorelbeke-Ramon A, Reybet-Degas O, Humeau-Chapuis MP, Alluin-Aigouy F, Fleury B, Jonquet O, Michard P. Mortality of sleep apnoea patients treated by nasal continuous positive airway pressure registered in the ANTADIR observatory. Association Nationale pour le Traitement A Domicile de l'Insuffisance Respiratoire chronique. Eur Respir J. 2000 Feb;15(2):326-31. doi: 10.1034/j.1399-3003.2000.15b18.x."}, {'pmid': '9817145', 'type': 'RESULT', 'citation': 'Veale D, Chailleux E, Taytard A, Cardinaud JP. Characteristics and survival of patients prescribed long-term oxygen therapy outside prescription guidelines. Eur Respir J. 1998 Oct;12(4):780-4. doi: 10.1183/09031936.98.12040780.'}, {'pmid': '9812404', 'type': 'RESULT', 'citation': 'Voisin C. [Medico-social management of severe respiratory insufficiency. Role of Associations]. Bull Acad Natl Med. 1998;182(6):1159-71; discussion 1172. French.'}, {'pmid': '8617085', 'type': 'RESULT', 'citation': 'Chailleux E, Fauroux B, Binet F, Dautzenberg B, Polu JM. Predictors of survival in patients receiving domiciliary oxygen therapy or mechanical ventilation. A 10-year analysis of ANTADIR Observatory. Chest. 1996 Mar;109(3):741-9. doi: 10.1378/chest.109.3.741.'}], 'seeAlsoLinks': [{'url': 'http://antadir.com', 'label': 'ANTADIR website'}]}, 'descriptionModule': {'briefSummary': 'An observatory of patients registered in 22 local homecare associations in France, for respiratory diseases, with annual data update. Demographic and clinical data are registered rendering possible extraction of clinical and prognostic data.', 'detailedDescription': 'Patients on treatment for respiratory failure and for sleep apnoea are registered on entry into treatment with recording of clincal and demographic data. Data available on age, sex, region, respiratoy function, blood gases, smoking status and some bilogical data'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients requiring respiratory support, in the ANTADIR homecare federation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* requiring respiratory support'}, 'identificationModule': {'nctId': 'NCT01181869', 'acronym': 'observatory', 'briefTitle': 'Database of Patients Treated With Respiratory Support', 'organization': {'class': 'OTHER', 'fullName': 'Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche'}, 'officialTitle': "Observatoire de l'ANTADIR - Database of Patients Registered as Treated With Respiratory Support in a Multicenter Homecare Federation for Patients Wirh Respiratory Problems", 'orgStudyIdInfo': {'id': 'observatoire antadir'}, 'secondaryIdInfos': [{'id': '1983', 'type': 'OTHER', 'domain': 'antadir'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oxygen therapy', 'description': 'Database of patients on oxygen', 'interventionNames': ['Device: oxygen']}, {'label': 'ventilation', 'description': 'database of patients on ventilatory support', 'interventionNames': ['Device: oxygen']}, {'label': 'Continuous positive airway pressure', 'description': 'Sleep apnoea patients on CPAP', 'interventionNames': ['Device: oxygen']}], 'interventions': [{'name': 'oxygen', 'type': 'DEVICE', 'otherNames': ['LTOT', 'NIV', 'CPAP'], 'description': 'oxygen therapy, ventilation for respiratory failure CPAP for sleep apnoea', 'armGroupLabels': ['Continuous positive airway pressure', 'Oxygen therapy', 'ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75006', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'ANTADIR', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Line Mounier, MSc', 'role': 'CONTACT', 'email': 'antadir@antadir.com', 'phone': '0033156814060'}, {'name': 'Dan Veale, MD', 'role': 'CONTACT', 'email': 'veale.dan@gmail.com', 'phone': '0033156814060'}], 'overallOfficials': [{'name': 'Daniel VEALE, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ANTADIR scientific committee'}, {'name': 'Jean Francois MUIR, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Daniel VEALE', 'investigatorAffiliation': 'Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche'}}}}