Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT05693051
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2023-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Prone Position Ventilation in Danish Patients With COVID-19 Induced Severe ARDS Treated With VV-ECMO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2023-01-18', 'studyFirstSubmitQcDate': '2023-01-18', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'From ECMO start to ECMO end (all causes)', 'description': 'Number and nature of adverse events related to prone position ventilation'}], 'primaryOutcomes': [{'measure': '90 day mortality', 'timeFrame': '90 days', 'description': 'all cause mortality 90 days after ECMO start'}], 'secondaryOutcomes': [{'measure': 'Time-to-wean', 'timeFrame': 'From start of ECMO treatment to succesful weaning from ECMO', 'description': 'Time from ECMO start to succesful weaning from ECMO'}, {'measure': 'Recruitment Response to prone position ventilation', 'timeFrame': 'from prone position start to prone position end', 'description': 'lung recruitment'}, {'measure': 'Oxygenation Response to prone position ventilation', 'timeFrame': 'from prone position start to prone position end', 'description': 'Oxygenation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ARDS', 'VV-ECMO', 'Prone position ventilation', 'Adverse Events'], 'conditions': ['ARDS, Human', 'Extracorporeal Membrane Oxygenation', 'COVID-19 Acute Respiratory Distress Syndrome', 'Prone Position', 'Adverse Event']}, 'descriptionModule': {'briefSummary': 'Prone position ventilation was used 220 times in 44 out of 68 patients with severe COVID-19 induced ARDS treated with VV-ECMO. PPV treated patients did not benefit from PPV and the incidence of PPV related adverse events was high', 'detailedDescription': 'Purpose: To describe the use and effects of prone position ventilation (PPV) in patients with COVID-19 induced Adult Respiratory Distress Syndrome (ARDS), treated with Veno-Venous Extracorporeal membrane oxygenation (VV-ECMO).\n\nMethods: Nationwide retrospective analysis of all COVID-19 patients in Denmark from March 2020 - December 2021with severe ARDS and need of VV-ECMO treatment. Data on the number of patients treated with PPV, number of PPV-events, timing, the time spent in prone position, physiological response types, adverse events and outcomes are reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a nationwide retrospective cohort study of a cohort of 68 patients with PCR confirmed SARS-Cov-2 ARDS, treated with V-V ECMO in the two VV-ECMO centers in Denmark: Aarhus University Hospital in west Denmark and University Hospital Rigshospitalet in Copenhagen, East Denmark. Patients were admitted in the period from 17. March 2020 to 31. December 2021.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: patients with COVID-19 induced severe ARDS accepted for and treated with VV-ECMO in Denmark\n\n\\-\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05693051', 'briefTitle': 'Use of Prone Position Ventilation in Danish Patients With COVID-19 Induced Severe ARDS Treated With VV-ECMO', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Use of Prone Position Ventilation (PPV) in Danish Patients With COVID-19 Induced Severe Adult Respiratory Distress Syndrome (ARDS) Treated With Veno-Venous Extracorporeal Membrane Oxygenation (VV-ECMO)', 'orgStudyIdInfo': {'id': '20049299-PPV'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Prone position ventilation', 'type': 'OTHER', 'description': 'Turning the patient prone for 16 hours'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital, CardioThoracic Intensive care Unit', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'University Hospital Rigshospitalet, department of CardioThoracic Anaesthesia and Intensive Care', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Vibeke L Jorgensen, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of CardioThoracic Anesthesia and Intensive Care, Rigshospitalet University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant, PhD, principal investigator', 'investigatorFullName': 'Vibeke Lind Jørgensen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}