Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-25 @ 7:37 PM
Study NCT ID:
NCT05531032
Status:
COMPLETED
Last Update Posted:
2025-04-13
First Post:
2022-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HRQOL of Life After ECMO Due to COVID-19.
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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Phone Interview'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2022-08-30', 'studyFirstSubmitQcDate': '2022-09-03', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HRQOL after COVID-19 ARDS and ECMO therapy', 'timeFrame': '1 year', 'description': 'Health-related quality of life will be delineated by means of a quantitative questionnaire.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ARDS', 'COVID-19 Pneumonia', 'Extracorporeal Membrane Oxygenation']}, 'descriptionModule': {'briefSummary': 'We intend to prospectively investigate physical and mental state (HRQOL) by means of quantitative telephone interviews after hospital discharge in patients surviving COVID-19 ARDS and ECMO therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients surviving COVID-19 ARDS and ECMO therapy\n\nExclusion Criteria:\n\n* no consent'}, 'identificationModule': {'nctId': 'NCT05531032', 'briefTitle': 'HRQOL of Life After ECMO Due to COVID-19.', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Health-related Quality of Life Following Extracorporeal Membrane Oxygenation Due to Coronavirus Disease 2019.', 'orgStudyIdInfo': {'id': '2440/2020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Phone Interview', 'type': 'OTHER', 'description': 'Phone interview questionnaire'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Alexander Hermann, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MUW'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Martina Hermann', 'investigatorAffiliation': 'Medical University of Vienna'}}}}