- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07404592
Tracheostomy Practices in Adult Intensive Care Units: A Multicenter Point-Prevalence Study in Izmir (IZ-TRACH) (IZ-TRACH)
June 16, 2026 updated by: Murat Kaykaç, Izmir City Hospital
Tracheostomy Practices in Adult Intensive Care Units in Izmir, Turkey: A Multicenter 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 characterize the documented reasons for postponement of tracheostomy, with attention to family-related deferral.
Secondary objectives included tracheostomy indications, techniques, complications, timing, the relationship between illness severity (APACHE II) and mortality, and short-term outcomes.
This multicenter, descriptive point-prevalence study was conducted across eleven adult ICUs in six hospitals on September 8, 2025.
Of 282 adult patients present on the index day, 46 had a tracheostomy and formed the analytic subgroup.
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 present on the prevalence day were screened; those with an established tracheostomy formed the analytic subgroup.
The data collection process involved:
- Documentation of ICU structural characteristics across eleven adult ICUs in six hospitals, including bed capacity and annual tracheostomy volumes.
- Evaluation of the interval from endotracheal intubation to tracheostomy and identification of documented reasons for any delay.
- Assessment of the association between APACHE II score and 30-day in-hospital mortality.
- A 30-day follow-up to assess mortality outcomes and causes of death.
Study Type
Observational
Enrollment (Actual)
282
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 (aged ≥18 years) present in eleven participating adult intensive care units across six hospitals in Izmir, Turkey, on the point-prevalence day.
Patients with a surgical or percutaneous tracheostomy formed the analytic subgroup.
Description
Inclusion Criteria:
- Aged 18 years and older
- Present in a participating adult ICU on the point-prevalence day
Exclusion Criteria:
- Patients younger than 18 years
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 in-hospital mortality from the index date
Time Frame: Up to 30 days after the index day
|
The proportion of patients who died within 30 days of the index (point-prevalence) date.
Because tracheostomies were prevalent (established before the survey), this is a point-prevalence snapshot rather than a procedure-anchored rate.
|
Up to 30 days after the index day
|
|
Point-prevalence of tracheostomy and documented reasons for postponement
Time Frame: Day 1
|
The proportion of adult ICU patients with a tracheostomy on the index day, and the distribution of documented reasons for postponement of tracheostomy (including family-related deferral).
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intubation-to-tracheostomy interval (days)
Time Frame: From endotracheal intubation to tracheostomy, assessed through Day 1
|
Median days from endotracheal intubation to tracheostomy
|
From endotracheal intubation to tracheostomy, assessed through Day 1
|
|
Distribution of tracheostomy technique (surgical vs percutaneous)
Time Frame: Day 1
|
Proportion of surgical versus percutaneous tracheostomies.
|
Day 1
|
|
Early and late complication rates by technique
Time Frame: From tracheostomy through Day 1
|
Proportion of patients with early and late complications, by technique.
|
From tracheostomy through Day 1
|
|
APACHE II score and its discrimination for 30-day mortality
Time Frame: Up to 30 days after the index day
|
Discrimination (area under the ROC curve) of the admission APACHE II score for 30-day mortality.
|
Up to 30 days after the index day
|
|
Causes of death among non-survivors
Time Frame: Up to 30 days after the index day
|
Distribution of causes of death among non-survivors.
|
Up to 30 days after the index day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Murat KAYKAC, M.D., İzmir City Hospital
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)
June 22, 2026
Last Update Submitted That Met QC Criteria
June 16, 2026
Last Verified
June 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.
Clinical Trials on Tracheostomy
-
University of MilanASST Santi Paolo e Carlo; Dejan Radovanovic; Marina Gatti; Michele Mondoni; Stefano... and other collaboratorsCompleted
-
Centre Hospitalier Universitaire, AmiensCompletedTracheostomy Hemorrhage | Tracheostomy Complications | Other Tracheostomy ComplicationsFrance
-
Universitatea de Medicina si Farmacie Iuliu HatieganuRecruitingTracheostomy Complication | Tracheostomy Infection | Tracheostomy HemorrhageRomania
-
Diskapi Yildirim Beyazit Education and Research...CompletedTracheostomy Complication | Percutaneous Tracheostomy | High-frequency Jet VentilationTurkey
-
Aksaray UniversityNot yet recruitingTracheostomy Complication | Percutaneous Tracheostomy | Airway Trauma | Tracheostomy HemorrhageTurkey
-
Shanghai Ninth People's Hospital, Shanghai Jiao...CompletedTracheostomy | Oral Cancer | Tracheostomy Complications | Post-Tracheostomy CareChina
-
Johns Hopkins UniversityNot yet recruitingTracheostomyUnited States
-
Capital Medical UniversityCompleted
-
Atos Medical ABCompleted
Clinical Trials on Tracheostomy
-
Heidelberg UniversityCompletedIschemic Stroke | Subarachnoid Hemorrhage | Intracerebral HemorrhageGermany
-
University of Erlangen-Nürnberg Medical SchoolTerminatedIntracerebral HemorrhageGermany
-
Memorial Medical CenterTerminatedRespiratory Failure | Traumatic Brain InjuryUnited States
-
The First Affiliated Hospital of Shanxi Medical...Completed
-
Makerere UniversityCompletedSevere Head InjuryUganda
-
Hillel Yaffe Medical CenterUnknownRespiratory InsufficiencyIsrael
-
University Hospital, Clermont-FerrandUnknown
-
University of ManitobaCompleted
-
Aykut SaritasProf.Dr.A.İlhan Özdemir State HospitalCompletedTracheostomy Complications
-
University of Sao PauloCompletedTracheostomy ComplicationsBrazil