NCT07404592

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 evaluate indications, techniques, complications, timing, and short-term outcomes. This multicentre, descriptive point-prevalence study was conducted across seven adult ICUs on September 8, 2025. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

1 month

First QC Date

February 5, 2026

Last Update Submit

February 5, 2026

Conditions

Keywords

TracheostomyIntensive care unitMechanical ventilationMultidisciplinary decision-makingPoint-prevalence study

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    The proportion of patients who died within 30 days following the tracheostomy procedure

    30 days post-procedure

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

TracheostomyPROCEDURE

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients followed in seven different intensive care units in Izmir, Turkey, who required a tracheostomy for various clinical indications, primarily prolonged mechanical ventilation.

You may qualify if:

  • Patients aged 18 years and older
  • Hospitalized in the participating adult intensive care units on the point-prevalence day
  • Previously undergone tracheostomy using either surgical or percutaneous techniques

You may not qualify if:

  • Patients younger than 18 years
  • Patients without a tracheostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir City Hospital

Izmir, Bayrakli, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Tracheostomy

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsOstomySurgical Procedures, OperativeOtorhinolaryngologic Surgical ProceduresThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
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

February 11, 2026

Record last verified: 2026-02

Locations