Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:04 AM
Study NCT ID:
NCT07404592
Status:
COMPLETED
Last Update Posted:
2026-02-11
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tracheostomy Practices in Adult Intensive Care Units: A Multicentre Study in Izmir
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014139', 'term': 'Tracheostomy'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010030', 'term': 'Ostomy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-05', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-02-05', 'lastUpdatePostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day mortality', 'timeFrame': '30 days post-procedure', 'description': 'The proportion of patients who died within 30 days following the tracheostomy procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tracheostomy', 'Intensive care unit', 'Mechanical ventilation', 'Multidisciplinary decision-making', 'Point-prevalence study'], 'conditions': ['Tracheostomy']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study was to determine the point prevalence of tracheostomy in adult intensive care units (ICUs) in Izmir and to evaluate indications, techniques, complications, timing, and short-term outcomes. This multicentre, descriptive point-prevalence study was conducted across seven adult ICUs on September 8, 2025. The study aimed to provide observational data on how tracheostomy is managed in a real-world clinical setting, focusing on the decision-making process and clinical characteristics associated with patient mortality', 'detailedDescription': 'This investigation was designed as a multicentre, descriptive point-prevalence study. On the specified prevalence day, all patients aged 18 years and older who had previously undergone tracheostomy using either surgical or percutaneous techniques in participating centers were included.\n\nThe data collection process involved:\n\n* Documentation of ICU structural characteristics, including bed capacity and annual tracheostomy volumes.\n* Systematic recording of patient demographics, comorbidities, tracheostomy indications, and the specific techniques used (e.g., Griggs guidewire dilating forceps, Ciaglia single-dilator, or surgical tracheostomy).\n* Assessment of early and post-procedural complications.\n* Evaluation of the time interval from endotracheal intubation to the tracheostomy procedure and identifying reasons for any delays.\n* A 30-day follow-up to assess mortality outcomes for all included patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients followed in seven different intensive care units in Izmir, Turkey, who required a tracheostomy for various clinical indications, primarily prolonged mechanical ventilation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years and older\n* Hospitalized in the participating adult intensive care units on the point-prevalence day\n* Previously undergone tracheostomy using either surgical or percutaneous techniques\n\nExclusion Criteria:\n\n* Patients younger than 18 years\n* Patients without a tracheostomy'}, 'identificationModule': {'nctId': 'NCT07404592', 'acronym': 'IZ-TRACH', 'briefTitle': 'Tracheostomy Practices in Adult Intensive Care Units: A Multicentre Study in Izmir', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Izmir City Hospital'}, 'officialTitle': 'TRACHEOSTOMY PRACTICES IN ADULT INTENSIVE CARE UNITS IN IZMIR, TURKEY: A MULTICENTRE POINT-PREVALENCE STUDY', 'orgStudyIdInfo': {'id': '2025/352'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tracheostomy Patients', 'description': 'Adult patients (aged ≥18 years) hospitalized in intensive care units who have undergone either surgical or percutaneous tracheostomy.', 'interventionNames': ['Procedure: Tracheostomy']}], 'interventions': [{'name': 'Tracheostomy', 'type': 'PROCEDURE', 'description': 'The application of surgical or percutaneous dilatational tracheostomy (Griggs guidewire dilating forceps or Ciaglia single-dilator techniques) for indications such as prolonged mechanical ventilation', 'armGroupLabels': ['Tracheostomy Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'state': 'Bayrakli', 'country': 'Turkey (Türkiye)', 'facility': 'Izmir City Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiology and Reanimation Specialist, MD', 'investigatorFullName': 'Murat Kaykaç', 'investigatorAffiliation': 'Izmir City Hospital'}}}}