Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2025-12-29 @ 6:44 AM
Study NCT ID:
NCT02551406
Status:
COMPLETED
Last Update Posted:
2016-02-26
First Post:
2015-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Value of Residual Hypoventilation in Mechanically Ventilated Neuromuscular Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-25', 'studyFirstSubmitDate': '2015-09-15', 'studyFirstSubmitQcDate': '2015-09-15', 'lastUpdatePostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first ICU admission', 'timeFrame': '6 years', 'description': 'Time to first ICU admission'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '6 years', 'description': 'Time to death'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nocturnal hypoventilation', 'capno-oxymetry'], 'conditions': ['Home Mechanical Ventilation', 'Neuromuscular Disease']}, 'referencesModule': {'references': [{'pmid': '27679799', 'type': 'DERIVED', 'citation': 'Ogna A, Nardi J, Prigent H, Quera Salva MA, Chaffaut C, Lamothe L, Chevret S, Annane D, Orlikowski D, Lofaso F. Prognostic Value of Initial Assessment of Residual Hypoventilation Using Nocturnal Capnography in Mechanically Ventilated Neuromuscular Patients: A 5-Year Follow-up Study. Front Med (Lausanne). 2016 Sep 13;3:40. doi: 10.3389/fmed.2016.00040. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': "Different tools may be used to monitor the efficacy of home mechanical ventilation. Investigators aimed to compare the prognostic value of the different data obtained by capno-oxymetry in a mechanical ventilated neuromuscular disease's population.", 'detailedDescription': 'Home mechanical ventilation (HMV) is used to treat hypoventilation, and its efficacy is mostly assessed by daytime blood gases and nocturnal oxymetry (SpO2). Transcutaneous CO2 measure (TcCO2) has shown higher sensitivity than SpO2 to detect hypoventilation in neuromuscular diseases (NMD) patients. No data exist on the prognostic value of these techniques to monitor mechanical ventilated NMD patients.\n\nBasing on retrospective data review, investigators aimed to compare the prognostic value of the data obtained using different tools to assess residual hypoventilation in the cohort of ventilated NMD patients followed at our reference center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ventilated neuromuscular disease patients followed at the Franch national reference center of Garches.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* neuromuscular disease\n* age ≥18 years\n* mechanically ventilated\n* capno-oxymetry performed between 2009 and 2011\n\nExclusion Criteria:\n\n* Long-term oxygen therapy'}, 'identificationModule': {'nctId': 'NCT02551406', 'acronym': 'TcCO2-VAD', 'briefTitle': 'Prognostic Value of Residual Hypoventilation in Mechanically Ventilated Neuromuscular Patients', 'organization': {'class': 'OTHER', 'fullName': "Centre d'Investigation Clinique et Technologique 805"}, 'officialTitle': 'Prognostic Value of Residual Hypoventilation in Mechanically Ventilated Neuromuscular Patients', 'orgStudyIdInfo': {'id': 'TcCO2-VAD'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Capno-oxymetry monitoring', 'type': 'DEVICE', 'description': 'Monitoring of home mechanical ventilation by capno-oximetry'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'state': 'Garches', 'country': 'France', 'facility': 'Hopital Raymond Poincare', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre d'Investigation Clinique et Technologique 805", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}