Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-01-05 @ 6:19 PM
Study NCT ID:
NCT05175859
Status:
COMPLETED
Last Update Posted:
2022-01-04
First Post:
2021-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Timing of Tracheostomy in COVID-19 - Impact on Mortality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-28', 'studyFirstSubmitDate': '2021-12-26', 'studyFirstSubmitQcDate': '2021-12-28', 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'During intensive care treatment (Usually within 8 weeks)', 'description': 'Deaths in the course of treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tracheostomy']}, 'descriptionModule': {'briefSummary': 'How timing of tracheostomy in COVID-19 patients changed and its impact on mortality in patients with severe COVID-19 ARDS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with underlying sheer COVID-19 disease and need for endotracheal airway management. Who required a tracheostomy due to the prolonged ventilation and ventilatory weaning required.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Severe COVID-19 infection requiring endotracheal intubation and prolonged invasive ventilation as part of the treatment of severe to moderate acute respiratory distress syndrome.\n\nExclusion Criteria:\n\n* COVID-19 disease, without the need for endotracheal ventilation.\n* COVID-19 disease with need for endotracheal intubation with anticipated short-term invasive ventilation.'}, 'identificationModule': {'nctId': 'NCT05175859', 'briefTitle': 'Timing of Tracheostomy in COVID-19 - Impact on Mortality', 'organization': {'class': 'OTHER', 'fullName': 'Goethe University'}, 'officialTitle': 'How Timing of Tracheostomy in COVID-19 Patients Changed and Its Impact on Mortality', 'orgStudyIdInfo': {'id': 'Tracheostomy in COVID-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early tracheostomy', 'description': 'Tracheostomy time before day 10 following endotracheal airway management and invasive ventilation.'}, {'label': 'Late tracheostomy', 'description': 'Tracheostomy time after day 11 following endotracheal airway management and invasive ventilation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Niederrad', 'state': 'Hesse', 'country': 'Germany', 'facility': 'University Hospital Frankfurt', 'geoPoint': {'lat': 50.08309, 'lon': 8.62852}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goethe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Armin N. Flinspach', 'investigatorAffiliation': 'Goethe University'}}}}