Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-04-04 @ 8:48 AM
Study NCT ID:
NCT02236104
Status:
COMPLETED
Last Update Posted:
2015-03-24
First Post:
2014-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Mechanical Insufflation-exsufflation on Respiratory Parameters in Two Neuromuscular Populations.
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-23', 'studyFirstSubmitDate': '2014-09-08', 'studyFirstSubmitQcDate': '2014-09-08', 'lastUpdatePostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximal inspiratory pressures', 'timeFrame': '2 hours', 'description': 'measure of maximal inspiratory pressures before mechanical insufflation-exsufflation session, just after this session and an hour after.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neuromuscular disorders', 'mechanical insufflation-exsufflation', 'respiratory parameters', 'plethysmography opto electronic', 'Vital capacity'], 'conditions': ['Mechanical Insufflation-exsufflation Session ( With Cough Assist)']}, 'descriptionModule': {'briefSummary': 'A single session of Mechanical Insufflation-Exsufflation (with Cough AssistÒ) may improve airway flow and gas exchange in neuromuscular atrophy patients. The goal of this study is to confirm the beneficial effects of this treatment in a larger neuromuscular population, to study its mechanisms of action and to assess whether the effects observed persist over time. A better knowledge of this treatment should help to define its position in the respiratory management of neuromuscular patients.', 'detailedDescription': '30 SMA and DMD adult patients will be recruited in the home ventilation unit of the intensive care department of Raymond Poincaré Hospital (Assistance Publique-Hôpitaux de Paris,Garches, France).\n\nRespiratory parameters and comfort will be evaluated before and after (5min,\n\n1h, 3h) a MI-E session. Vital capacity, maximal inspiratory and expiratory pressures (PImax and PEmax), peak cough flow and peak expiratory flows will be measured. Breathing pattern will be recorded allowing the measurements of respiratory frequency, tidal volume, Inspiratory time (Ti),total breath (Ttot) during tidal breathing and the calculation of tension-time index (TT0.1).\n\nGas exchange will be evaluated by measuring end tidal CO2, transcutaneous CO2 and pulse oxymetry.\n\nRespiratory comfort will be assessed with a visual analog scale. Optoelectronic plethysmography will be use to perform regional ventilation evaluation. Using chest wall motion analysis we will compute respiratory participation of upper, lower thorax and abdomen, right and left side.\n\nResults should allow to analyse the effects of MI-E on regional ventilation. The mechanisms of action of MI-E on respiration and chest-wall motion will be analysed and the persistence of the beneficial effect of MI-E will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged more than 18 years\n* Written consents\n* Neuromuscular disorders\n* Hemodynamic stability\n\nExclusion Criteria:\n\n* Pulmonary disorder\n* Acute respiratory failure\n* Cognitive deficit'}, 'identificationModule': {'nctId': 'NCT02236104', 'acronym': 'coughassistAFM', 'briefTitle': 'Effect of Mechanical Insufflation-exsufflation on Respiratory Parameters in Two Neuromuscular Populations.', 'organization': {'class': 'OTHER', 'fullName': "Centre d'Investigation Clinique et Technologique 805"}, 'officialTitle': 'Effect of Mechanical Insufflation-exsufflation on Respiratory Parameters in Two Neuromuscular Populations.', 'orgStudyIdInfo': {'id': '2010-A01042-37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cough assist session', 'description': 'Mechanical insufflation-exsufflation contains 15 cycles durea 2-3 seconds. pressure level fixed +/-30 cm H2O.', 'interventionNames': ['Device: Plethysmography opto electronic', 'Procedure: respiratory parameters']}], 'interventions': [{'name': 'Plethysmography opto electronic', 'type': 'DEVICE', 'armGroupLabels': ['cough assist session']}, {'name': 'respiratory parameters', 'type': 'PROCEDURE', 'armGroupLabels': ['cough assist session']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'state': 'Garches', 'country': 'France', 'facility': 'Hopital Raymond Poincaré', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'overallOfficials': [{'name': 'Frederic LOFASO, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Raymond poincare hospital'}, {'name': 'Michel Petitjean, MDPHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Raymond Poincare hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre d'Investigation Clinique et Technologique 805", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Versailles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}