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

This completed observational study describes physician-reported reasons for postponement among adults with an established tracheostomy who were present in participating intensive care units (ICUs) on a single survey day. The survey was conducted in eleven adult ICUs in six hospitals in Izmir, Turkey, on 8 September 2025. The census comprised 282 adults; 46 had a tracheostomy. All 46 contribute to the prevalence numerator. The main descriptive sample comprises 42 patients whose tracheostomy was established during the current admission; four patients with tracheostomies created before admission are excluded from patient-level clinical and outcome summaries. Previous clinical and procedural information was collected retrospectively, and postponement reasons were obtained from primary treating physicians. Mortality was assessed 30 days after the index day, on 8 October 2025. Analyses describe reason categories, total intubation-to-tracheostomy intervals, patient and procedural characteristics, recorded complications, and post-index in-hospital mortality. They cannot establish the duration attributable to family decision-making, preventability of postponement, or effects on outcomes. Registration and this clarification occurred after study completion; no prospective specification of the revised analyses is claimed.

Conditions

Tracheostomy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Recorded 30-day post-index in-hospital mortality

  Proportion of the 42 current-admission tracheostomy patients with a recorded in-hospital death during the 30 days after the index-day census. Status was assessed by local investigators from records and the hospital information system on 8 October 2025. The time origin is 8 September 2025, not tracheostomy or ICU admission. Individual calendar death dates and discharge/transfer histories were unavailable in the available analysis dataset. The current 42-patient denominator was adopted during manuscript revision after study completion; exploratory reason-group summaries do not establish causal effects.

  From the index date, 8 September 2025, to the follow-up assessment on 8 October 2025 (30 days)

• Point-prevalence of tracheostomy and physician-reported reasons for postponement

  Prevalence is the number with any established tracheostomy (46) divided by the full adult ICU census (282) on the index day. Reason distributions use the 42 current-admission tracheostomy patients. Primary treating physicians reported family-related reasons, hemodynamic instability, awaiting surgical eligibility or bleeding diathesis. Each patient had at most one reason reported; multiple reasons would have been recorded if reported. No reported reason does not demonstrate absence of postponement. These categories do not measure days attributable to family decisions or establish preventability. The 42-patient restriction and revised descriptive presentation were adopted after study completion.

  Index-day census on 8 September 2025; preceding postponement reasons obtained retrospectively from treating physicians

Secondary Outcomes (5)

• Total intubation-to-tracheostomy interval (days)

  From endotracheal intubation to tracheostomy, retrospectively assessed through 8 September 2025

• Distribution of tracheostomy techniques

  Tracheostomies established before and present on the index day, 8 September 2025

• Recorded early and late tracheostomy complications

  From each patient's tracheostomy through the index day, 8 September 2025; observation duration varied between patients

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

  APACHE II assessed once at ICU admission; vital status assessed 30 days after the index date (8 September to 8 October 2025)

• Causes of death among non-survivors

  Up to 30 days after the index day

Study Arms (1)

Tracheostomy Patients

Adults aged 18 years or older with an established surgical or percutaneous tracheostomy who were present in a participating ICU on 8 September 2025. This group comprised 46 of the 282 adults in the census. The revised main descriptive analyses include 42 patients with tracheostomy established during the current admission; four with tracheostomy created before admission contribute only to prevalence and exclusion accounting. Tracheostomy was provided as clinical care and was not assigned by investigators.

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

Adults aged 18 years or older present in eleven participating adult ICUs across six hospitals in Izmir, Turkey, on 8 September 2025 formed the 282-person census. Forty-six had a surgical or percutaneous tracheostomy and contribute to overall prevalence. The main descriptive sample includes the 42 whose tracheostomy was established during the current admission. Four with tracheostomies created before admission are included only in census/prevalence counts and exclusion accounting. This revision of the analysis population does not change the census eligibility criteria or actual enrollment of 282.

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: September 22, 2026

Record last verified: 2026-09

Locations

TU (1)