Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-25 @ 3:10 PM
Study NCT ID:
NCT03854968
Status:
COMPLETED
Last Update Posted:
2019-08-07
First Post:
2019-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality Control of Home Mechanical Ventilators
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011786', 'term': 'Quality Control'}], 'ancestors': [{'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-06', 'studyFirstSubmitDate': '2019-02-15', 'studyFirstSubmitQcDate': '2019-02-25', 'lastUpdatePostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure', 'timeFrame': '20 minutes', 'description': 'ventilator pressures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mechanical ventilation', 'Performance'], 'conditions': ['Mechanical Ventilation']}, 'descriptionModule': {'briefSummary': 'A multicentre quality control survey of home mechanical ventilation in patients. The prescribed ventilation settings, the settings of the ventilator control panel and the actual performance of the ventilator will be tested.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Home mechanically ventilated\n* \\>18 years\n\nExclusion Criteria:\n\n* Pacients with servoventilation'}, 'identificationModule': {'nctId': 'NCT03854968', 'briefTitle': 'Quality Control of Home Mechanical Ventilators', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Quality Control Of Home Mechanical Ventilated Patient Mechanical Ventilators. A Multicenter Study', 'orgStudyIdInfo': {'id': 'VENTEST_2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quality control', 'description': 'The participants home mechanical ventilator will be tested in order to performe a quality control', 'interventionNames': ['Other: Quality control']}], 'interventions': [{'name': 'Quality control', 'type': 'OTHER', 'description': 'The performance of the home mechanical ventilator of all patients in the study will be evaluated with a portable device', 'armGroupLabels': ['Quality control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Josep M Montserrat, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jose M. Montserrat', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}