Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT04412356
Status:
COMPLETED
Last Update Posted:
2021-09-22
First Post:
2020-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Timing of Tracheotomy in Covid-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014140', 'term': 'Tracheotomy'}], 'ancestors': [{'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients will be blinded to the randomization outcome.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, single blinded, controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-20', 'studyFirstSubmitDate': '2020-05-24', 'studyFirstSubmitQcDate': '2020-05-31', 'lastUpdatePostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mechanical ventilation', 'timeFrame': 'Through the individual ICU stay assessed up to 60 days', 'description': 'Number of days with mechanical ventilation'}], 'secondaryOutcomes': [{'measure': 'ICU stay', 'timeFrame': 'Through the individual ICU stay assessed up to 60 days', 'description': 'Number of days at ICU'}, {'measure': 'Oxygen support', 'timeFrame': 'Through the individual ICU stay assessed up to 60 days', 'description': 'Number of days with need of additional oxygen support'}, {'measure': 'Sedation', 'timeFrame': 'Through the individual ICU stay assessed up to 60 days', 'description': 'Number of days with the need of sedation'}, {'measure': 'Adverse events', 'timeFrame': 'Through the individual ICU stay assessed up to 60 days', 'description': 'Various adverse events associated with the tracheotomy/tracheostomy'}, {'measure': 'Mortality', 'timeFrame': 'Through the individual ICU stay assessed up to 90 days', 'description': 'Mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid-19', 'Tracheotomy', 'Tracheostomy', 'RCT', 'ARDS'], 'conditions': ['Covid-19', 'ARDS', 'Tracheostomy Complication', 'Respiratory Insufficiency', 'Corona Virus Infection']}, 'referencesModule': {'references': [{'pmid': '35585614', 'type': 'DERIVED', 'citation': 'Eeg-Olofsson M, Pauli N, Hafsten L, Jacobsson J, Lundborg C, Brink M, Larsson H, Lindell E, Lowhagen K, Gisslen M, Bergquist H. TTCOV19: timing of tracheotomy in SARS-CoV-2-infected patients: a multicentre, single-blinded, randomized, controlled trial. Crit Care. 2022 May 18;26(1):142. doi: 10.1186/s13054-022-04005-0.'}]}, 'descriptionModule': {'briefSummary': 'Critically ill covid-19 patients may require respiratory support including mechanical ventilation. After an initial period with an endotracheal tube, a tracheotomy is performed in order to reduce potential airway complications, reduce the need of sedation and facilitate the monitoring and recovery. The optimal timing of this surgical procedure is, however, still unknown. The aim of this randomized, controlled trial is to compare the outcome of early (within 7 days after intubation) vs late (at least 10 days after intubation) tracheotomy in covid-19 patients. The need for mechanical ventilation, sedation, additional oxygen support, frequency of complications, duration at the ICU and mortality through the ICU stay will be evaluated and compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Verified Covid-19 infection\n* Intubated due to respiratory insufficiency and need for mechanical ventilation\n* Informed consent from patient or relative\n\nExclusion Criteria:\n\n* Age below 18 years\n* Need for mechanical ventilation less than 14 days\n* Tracheotomy not possible within 7 days\n* Tracheotomy not possible due to anatomical or other medical reasons'}, 'identificationModule': {'nctId': 'NCT04412356', 'acronym': 'TTCOV19', 'briefTitle': 'Timing of Tracheotomy in Covid-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'Timing of Tracheotomy in Covid-19 Positive Patients: a Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'HBergquist'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early tracheotomy', 'description': 'Tracheotomy within 7 days after intubation.', 'interventionNames': ['Procedure: Tracheotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Late tracheotomy', 'description': 'Tracheotomy after at least 10 days after intubation.', 'interventionNames': ['Procedure: Tracheotomy']}], 'interventions': [{'name': 'Tracheotomy', 'type': 'PROCEDURE', 'description': 'Surgical procedure to secure airway', 'armGroupLabels': ['Early tracheotomy', 'Late tracheotomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Henrik Bergquist, Assoc Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Associate Professor', 'investigatorFullName': 'Henrik Bergquist', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}