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

Status

Completed

Conditions

Intervention / Treatment

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

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.

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

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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