Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT01615432
Status:
COMPLETED
Last Update Posted:
2013-05-16
First Post:
2012-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Synchrony Between 4 NIV Ventilators
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-15', 'studyFirstSubmitDate': '2012-06-06', 'studyFirstSubmitQcDate': '2012-06-06', 'lastUpdatePostDateStruct': {'date': '2013-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-ventilator synchrony', 'description': 'Patient-ventilator synchrony will be assessed breath by brath on the basis of airway pressure, flow and diaphragmatic electrical activity recordings.'}], 'secondaryOutcomes': [{'measure': 'comfort of patient under NIV', 'description': "Patient's confort during NIV will be assessed using a visual analogic scale."}, {'measure': 'Ventilatory parameters', 'description': 'Tidal volume, respiratory rate, inspiratory time, expiratory time and maximal and mean airway pressure will be measured from the continuous recording of airway pressure and flow.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Respiratoy Failure Requiring NIV Treatment']}, 'descriptionModule': {'briefSummary': 'Comparison of the effects of 4 ventilators dedicated to NIV (2 home ventilators and 2 ventilators designed for NIV) on patient-ventilator synchrony and comfort in patients admitted in the intensive care unit for respiratory failure and treated with NIV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* respiratory failure\n\nExclusion Criteria:\n\n* Severe hypoxemia requiring an FiO2 \\> 0.6\n* Hemodynamic instability : defined as a variation of \\> 20% in mean arterial pressure (MAP) and heart rate (HR) during the previous 2 hours; the need for high doses of catecholamines (namely \\> 0.5 mcg/kg/min) and/or the need of major volume resuscitation (more than 2 liters of fluids in 2 hours)\n* Impaired consciousness or absence of patient cooperation;\n* Facial or laryngeal lesions contraindicating the use of NIV;\n* Poor short term prognosis.\n* Age \\< 18 years old'}, 'identificationModule': {'nctId': 'NCT01615432', 'briefTitle': 'Comparison of Synchrony Between 4 NIV Ventilators', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne Hospitals'}, 'officialTitle': 'Comparison of Four Different Ventilators for Noninvasive Ventilation in Terms of Patient-ventilator Synchrony and Comfort', 'orgStudyIdInfo': {'id': 'Synchro_Non invasive vent'}}, 'armsInterventionsModule': {'interventions': [{'name': 'V-PAP III ventilator', 'type': 'DEVICE'}, {'name': 'Stellar 150 ventilator', 'type': 'DEVICE'}, {'name': 'BiPAP vision ventilator', 'type': 'DEVICE'}, {'name': 'V60 ventilator', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Intensive care and burn unit / CHUV', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Main investigator', 'investigatorFullName': 'Prof. Philippe Jolliet', 'investigatorAffiliation': 'University of Lausanne Hospitals'}}}}