- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07404592
Tracheostomy Practices in Adult Intensive Care Units: A Multicentre Study in Izmir (IZ-TRACH)
February 5, 2026 updated by: Murat Kaykaç, Izmir City Hospital
TRACHEOSTOMY PRACTICES IN ADULT INTENSIVE CARE UNITS IN IZMIR, TURKEY: A MULTICENTRE POINT-PREVALENCE STUDY
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
Study Overview
Detailed Description
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.
The data collection process involved:
- Documentation of ICU structural characteristics, including bed capacity and annual tracheostomy volumes.
- 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).
- Assessment of early and post-procedural complications.
- Evaluation of the time interval from endotracheal intubation to the tracheostomy procedure and identifying reasons for any delays.
- A 30-day follow-up to assess mortality outcomes for all included patients.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bayrakli
-
Izmir, Bayrakli, Turkey (Türkiye)
- İzmir City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients followed in seven different intensive care units in Izmir, Turkey, who required a tracheostomy for various clinical indications, primarily prolonged mechanical ventilation.
Description
Inclusion Criteria:
- Patients aged 18 years and older
- Hospitalized in the participating adult intensive care units on the point-prevalence day
- Previously undergone tracheostomy using either surgical or percutaneous techniques
Exclusion Criteria:
- Patients younger than 18 years
- Patients without a tracheostomy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Tracheostomy Patients
Adult patients (aged ≥18 years) hospitalized in intensive care units who have undergone either surgical or percutaneous tracheostomy.
|
The application of surgical or percutaneous dilatational tracheostomy (Griggs guidewire dilating forceps or Ciaglia single-dilator techniques) for indications such as prolonged mechanical ventilation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30-day mortality
Time Frame: 30 days post-procedure
|
The proportion of patients who died within 30 days following the tracheostomy procedure
|
30 days post-procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 8, 2025
Primary Completion (Actual)
October 8, 2025
Study Completion (Actual)
October 8, 2025
Study Registration Dates
First Submitted
February 5, 2026
First Submitted That Met QC Criteria
February 5, 2026
First Posted (Actual)
February 11, 2026
Study Record Updates
Last Update Posted (Actual)
February 11, 2026
Last Update Submitted That Met QC Criteria
February 5, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/352
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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