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Completed

NCT Number: NCT07404592

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

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.

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Key information

Conditions

Tracheostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Izmir City Hospital

Izmir, Bayrakli, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. Intubation-to-tracheostomy interval (days)

    Time frame: From endotracheal intubation to tracheostomy, assessed through Day 1

    Median days from endotracheal intubation to tracheostomy

  2. Distribution of tracheostomy technique (surgical vs percutaneous)

    Time frame: Day 1

    Proportion of surgical versus percutaneous tracheostomies.

  3. Early and late complication rates by technique

    Time frame: From tracheostomy through Day 1

    Proportion of patients with early and late complications, by technique.

  4. 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.

  5. Causes of death among non-survivors

    Time frame: Up to 30 days after the index day

    Distribution of causes of death among non-survivors.

Sponsors and collaborators

Lead sponsor

Izmir City Hospital

Other Gov

Registry information

Official study title

Tracheostomy Practices in Adult Intensive Care Units in Izmir, Turkey: A Multicenter Point-Prevalence Study

Acronym: IZ-TRACH

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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