Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT00189527
Status:
COMPLETED
Last Update Posted:
2011-02-17
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assist Control Versus Pressure Support Modes for Domiciliary Noninvasive Ventilation in Chronic Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-16', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PaO2', 'timeFrame': 'months', 'description': 'Blood gases response to ventilation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'Noninvasive ventilation is a therapeutic option in some patients with chronic respiratory failure. Patients usually ventilate during nightime with a domiciliary ventilator either in assist control or in pressure support mode.\n\nThe aim of this study is to compare the clinical efficacy and the tolerance of assist control and pressure support modes during domiciliary noninvasive ventilation in patients with chronic respiratory failure.', 'detailedDescription': 'The aim of this study is to compare the clinical efficacy and the tolerance of assist control and pressure support modes during domiciliary noninvasive ventilation in patients with chronic respiratory failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic respiratory failure\n* Clinical symptoms of chronic alveolar hypoventilation\n* PaCO2 ≥ 45 mmHg in case of restrictive pulmonary disorder or PaCO2 ≥ 55 mmHg in case or obstructive pulmonary disorder\n\nExclusion Criteria:\n\n* Clinical exacerbation during the three previous weeks\n* Previous treatment by domiciliary non invasive ventilation\n* Previous treatment by non invasive ventilation for acute respiratory failure during the 3 previous months\n* Bronchiectasis\n* Duchenne muscular dystrophy\n* Amyotrophic lateral sclerosis'}, 'identificationModule': {'nctId': 'NCT00189527', 'briefTitle': 'Assist Control Versus Pressure Support Modes for Domiciliary Noninvasive Ventilation in Chronic Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche'}, 'officialTitle': 'Assist Control Versus Pressure Support Modes for Domiciliary Noninvasive Ventilation', 'orgStudyIdInfo': {'id': '2000-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'respiratory support', 'description': 'a mode of ventilation in comparison', 'interventionNames': ['Procedure: respiratory settings']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Assist Control', 'description': 'an other mode of ventilation in comparison', 'interventionNames': ['Procedure: respiratory settings']}], 'interventions': [{'name': 'respiratory settings', 'type': 'PROCEDURE', 'armGroupLabels': ['Assist Control', 'respiratory support']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Antoine CUVELIER, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Rouen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Pr A Cuvelier', 'oldOrganization': 'CHU Rouen'}}}}