Tracheostomy Practices in Adult Intensive Care Units: A Multicenter Point-Prevalence Study in Izmir (IZ-TRACH)

NCT07404592 | Completed

• 1 other identifier: 2025/352
• Study Type: observational
• Target: 282
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tracheostomy

Keywords

Tracheostomy; Intensive care unit; Mechanical ventilation; Multidisciplinary decision-making; Point-prevalence study

Outcome Measures

Primary Outcomes (2)

• 30-day in-hospital mortality from the index date

  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

  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 Outcomes (5)

• Intubation-to-tracheostomy interval (days)

  From endotracheal intubation to tracheostomy, assessed through Day 1

• Distribution of tracheostomy technique (surgical vs percutaneous)

  Day 1

• Early and late complication rates by technique

  From tracheostomy through Day 1

• APACHE II score and its discrimination for 30-day mortality

  Up to 30 days after the index day

• Causes of death among non-survivors

  Up to 30 days after the index day

Study Arms (1)

Tracheostomy Patients

Adult patients (aged ≥18 years) hospitalized in intensive care units who have undergone either surgical or percutaneous tracheostomy.

Procedure: Tracheostomy

Interventions

Tracheostomy PROCEDURE

The application of surgical or percutaneous dilatational tracheostomy (Griggs guidewire dilating forceps or Ciaglia single-dilator techniques) for indications such as prolonged mechanical ventilation

Tracheostomy Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Aged 18 years and older
• Present in a participating adult ICU on the point-prevalence day

You may not qualify if:

• Patients younger than 18 years

Sponsors & Collaborators

• Izmir City Hospital: lead

Study Sites (1)

Izmir City Hospital

Izmir, Bayrakli, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Tracheostomy

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Ostomy; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Murat KAYKAC, M.D.

  Izmir City Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 30 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Specialist, MD

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 11, 2026
• Study Start: September 8, 2025
• Primary Completion: October 8, 2025
• Study Completion: October 8, 2025
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

TU (1)