Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-30 @ 5:51 PM
Study NCT ID:
NCT01143103
Status:
WITHDRAWN
Last Update Posted:
2012-09-24
First Post:
2010-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Respiratory Therapy With Cough Assist Technique and Usual Respiratory Therapy in Intensive Care Patients Suffering of Neurologic Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-21', 'studyFirstSubmitDate': '2010-06-02', 'studyFirstSubmitQcDate': '2010-06-11', 'lastUpdatePostDateStruct': {'date': '2012-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of stay in intensive care unit'}, {'measure': 'Number of additional unplanned respiratory therapy treatment'}], 'secondaryOutcomes': [{'measure': 'Duration of stay in the hospital'}, {'measure': 'Pulmonary infection'}, {'measure': 'Oxygenation parameters before and after respiratory therapy'}, {'measure': 'Intracranial pressure elevation during respiratory therapy if an intracerebral pressure monitoring is available'}, {'measure': 'Need of reintubation in the 48h following successful intubation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Respiratory therapy in neurologic disorder'], 'conditions': ['Neurologic Disorder']}, 'descriptionModule': {'briefSummary': 'The present study aims to compare the efficiency of respiratory therapy with cough assist and the efficiency of usual respiratory therapy in intensive care patients suffering of neurologic disorder and cough ineffectiveness. The investigators hypothesis is that cough assist is more efficient than usual respiratory care in this group of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Peak flow \\< 270 ml if the patient has one of the following diagnostic: post neurosurgery status, cerebral trauma, tetraparesia or tetraplegia\n\nExclusion Criteria:\n\n* Death expected in the following 24h\n* Bulbar dysfunction if extubated\n* pneumothorax\n* intracerebral mass effect\n* elevated intracranial pressure'}, 'identificationModule': {'nctId': 'NCT01143103', 'briefTitle': 'Comparison Between Respiratory Therapy With Cough Assist Technique and Usual Respiratory Therapy in Intensive Care Patients Suffering of Neurologic Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Comparison Between Respiratory Physiotherapy With Cough Assist Technique and Usual Respiratory Care in Intensive Care Patients Suffering of Neurologic Disorder', 'orgStudyIdInfo': {'id': 'cough assist'}, 'secondaryIdInfos': [{'id': 'cough assist', 'type': 'OTHER', 'domain': 'University hospital of Geneva'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Respiratory therapy with cough assist', 'interventionNames': ['Device: Cough assist (Philips,respironics)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual respiratory therapy', 'interventionNames': ['Other: Usual respiratory therapy']}], 'interventions': [{'name': 'Cough assist (Philips,respironics)', 'type': 'DEVICE', 'armGroupLabels': ['Respiratory therapy with cough assist']}, {'name': 'Usual respiratory therapy', 'type': 'OTHER', 'armGroupLabels': ['Usual respiratory therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'University hospital of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Didier Tassaux', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Geneva'}, {'name': 'Lise Piquilloud', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Geneva'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Didier Tassaux, MD', 'oldOrganization': 'Intensive care unit, university hospital of Geneva'}}}}