Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT06138093
Status:
COMPLETED
Last Update Posted:
2024-12-20
First Post:
2023-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-22', 'size': 9669294, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-07T07:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2023-11-07', 'studyFirstSubmitQcDate': '2023-11-13', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced expiratory volume in one second (FEV1)', 'timeFrame': 'Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention', 'description': 'Lung function / air flow evaluated by spirometry'}, {'measure': 'Voice quality', 'timeFrame': 'Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention', 'description': 'Evaluated by Equal-Appearing Interval Scale ranging from 1 to 5, where 5 represents a normal voice quality and 1 represents a severely impaired voice'}, {'measure': 'Peak expiratory flow (PEF)', 'timeFrame': 'Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention', 'description': 'Lung function / air flow evaluated by spirometry'}, {'measure': 'Forced vital capacity (FVC)', 'timeFrame': 'Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention', 'description': 'Lung function / air flow evaluated by spirometry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tracheostomy', 'respiratory insufficiency', 'respiratory function tests', 'mechanical ventilators', 'rehabilitation', 'critical care'], 'conditions': ['Tracheostomy']}, 'referencesModule': {'references': [{'pmid': '38672206', 'type': 'DERIVED', 'citation': 'Kraghede RE, Christiansen KJ, Kaspersen AE, Pedersen M, Petersen JJ, Hasenkam JM, Devantier L. Novel Method for Sealing Tracheostomies Immediately after Decannulation-An Acute Clinical Feasibility Study. Biomedicines. 2024 Apr 12;12(4):852. doi: 10.3390/biomedicines12040852.'}]}, 'descriptionModule': {'briefSummary': 'Tracheostomy is performed for prolonged mechanical ventilation. Ineffective bandaging following decannulation leaves the tracheostomy wound unsealed, reducing pulmonary function, coughing ability, and voice quality, ultimately leading to decannulation failure. Recently, a new concept enabling intratracheal sealing of the tracheotomy was introduced, potentially solving the issues of air leakage and tracheal wound infection. This study aims to investigate the feasibility of intratracheal tracheostomy sealing in relation to an immediate normalization of physiological airway flow and an improved voice quality.', 'detailedDescription': 'See protocol document.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Tracheostomy for minimum 7 days\n* Age \\> 18 years\n* Capped uncuffed tube size 7 or 8 for at least 24 hours\n\nExclusion Criteria:\n\n* Cognitive dysfunction (patients who are not able to cooperate with investigation)'}, 'identificationModule': {'nctId': 'NCT06138093', 'briefTitle': 'Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation', 'orgStudyIdInfo': {'id': '74553'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sealed / closed tracheostomy', 'description': 'Sealing of the tracheostomy wound using a sealing device.', 'interventionNames': ['Device: Sealing device', 'Device: No device']}], 'interventions': [{'name': 'Sealing device', 'type': 'DEVICE', 'description': 'Intratracheal tracheostomy sealing', 'armGroupLabels': ['Sealed / closed tracheostomy']}, {'name': 'No device', 'type': 'DEVICE', 'description': 'Open tracheostomy wound', 'armGroupLabels': ['Sealed / closed tracheostomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Anaesthesiology and Intensive Care, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Rasmus E Kraghede, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology and Intensive Care, Aarhus University Hospital'}, {'name': 'J. Michael Hasenkam, MD, DMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}