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TracheostomyIZ-TRACHNCT07404592

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

An observational study of Tracheostomy, run by Izmir City Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tracheostomy
What is being tested?
Tracheostomy
Type of treatment
Surgery or procedure
How many people
282 participants
Where
1 siteTurkey (Türkiye)
Study dates
8 Sep 2025to 8 Oct 2025
How long will I take part?
30 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Patients younger than 18 years

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Izmir City Hospital

    Izmir, Bayrakli

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the detailed description

Design and populations

This was a multicenter point-prevalence survey on 8 September 2025 with a subsequent assessment of recorded in-hospital mortality on 8 October 2025. The census included 282 adults present in eleven participating ICUs across six hospitals. Forty-six had an established tracheostomy and contribute to the point-prevalence numerator. The main descriptive sample comprises 42 patients whose tracheostomy was established during the current admission. Four with pre-admission tracheostomies remain in the census and prevalence counts but are excluded from the main patient-level summaries. Patients who died or left the ICU before the index day and patients who had not undergone tracheostomy by that date are absent from this sample.

Data collection and compilation

The initial compilation contained 30 tracheostomy patients from seven ICUs. Records for another 16 patients from four additional ICUs within one participating hospital were subsequently incorporated, yielding 46 tracheostomy patients across eleven ICUs. Their postponement reports were obtained on the same index day, 8 September 2025; the records were merged later. Of these 16 patients, three had pre-admission tracheostomies. The remaining 13 contributed to the main analysis, and four had a family-related reason.

Six hospital contact physicians submitted the online forms using information from eleven primary treating physicians, one for each ICU. At the hospital comprising six ICUs, the contact physician collated information from all six primary physicians, including the contact physician's own ICU. Each of the other five hospitals contributed one ICU. Participation in the original tracheostomy decision was not recorded, and reports may have concerned decisions made by colleagues.

Physician-reported reasons and intervals

The index-day form asked: "Please specify any factors that caused tracheostomy to be performed late." Examples included high-dose inotropic support and lack of consent from relatives. This wording assumed lateness and may have influenced responses. Fourteen patients had an explicit "No documented delay" response; none of the 42 responses was blank. These patients are described as having no reported postponement reason, which does not independently establish absence of postponement. Other recorded categories were a family-related reason, hemodynamic instability, awaiting surgical eligibility and bleeding diathesis. Multiple reasons and an "Other" free-text option were allowed; neither was used. Investigators did not select a predominant reason from multiple responses.

A family-related reason represents the physician's account of deliberation or agreement involving relatives or a surrogate decision-maker, not a demonstrated avoidable delay. The measured interval is total time from intubation to tracheostomy. Intended procedure dates, recommendation dates, discussion/agreement dates and clinical readiness dates were unavailable, so time attributable to an individual reason cannot be calculated.

Recorded complications and mortality

Complications were identified retrospectively from records through the index day. The form presented separate early- and late-complication items with prelisted event types. No seven-day boundary was communicated to respondents. These questionnaire categories were retained in the analysis; individual event dates were unavailable, so classification as occurring within or after seven days cannot be verified. Recorded early-item events were hemorrhage, subcutaneous emphysema and hypoxia/desaturation; late-item events were granuloma, stoma infection and tracheoesophageal fistula. Observation periods were unequal and unmeasured; these are recorded category counts rather than standardized procedure-anchored incidence estimates.

Recorded in-hospital deaths between 8 September and 8 October 2025 were ascertained from local records and the hospital information system. This is 30-day post-index in-hospital mortality, not mortality within 30 days of tracheostomy or ICU admission. A zero mortality code denotes no recorded in-hospital death; it does not establish survival or continued hospitalization at follow-up. Individual calendar death dates and discharge/transfer histories were unavailable in the retained analysis data. Tracheostomy-to-death intervals are summarized only among patients with a recorded death; comparable procedure-to-censoring intervals are unavailable for the others.

Descriptive analyses

The analyses report counts and percentages with explicit denominators and medians with interquartile ranges and ranges. Patient-level summaries use the 42 current-admission patients. Reason-group outcome counts and admission APACHE II summaries by recorded in-hospital death status are exploratory and were not prospectively specified. Technique is described as a procedural characteristic; outcomes are not compared by technique. No hypothesis tests, adjusted comparisons, causal effects, equivalence claims or survival analyses are presented. Earlier ROC/cutoff and early-versus-late timing analyses are not retained.

Registration chronology

Data collection was completed on 8 October 2025. The initial registry submission was on 5 February 2026 and first posting on 11 February 2026. That entry described 30 tracheostomy patients in seven ICUs and mortality within 30 days after tracheostomy as its only structured outcome. An amendment submitted on 16 June 2026 and posted on 22 June 2026 changed enrollment to the 282-patient census, described eleven ICUs and the 46-patient tracheostomy subgroup, changed the mortality anchor to the index date, and added structured outcomes. The change from 30 to 282 also changed the population represented by the enrollment field, from a tracheostomy subgroup to the full ICU census.

The explanation released for PRS review on 19 October 2026 that the discrepancy was solely a registry-entry error was incorrect. The compilation history is clarified above: 16 records collected on the index day were incorporated after the initial 30-record compilation. This amendment also corrects the unsupported seven-day complication definition and distinguishes form submitters from clinical information sources. These retrospective entries and amendments do not establish prospective specification of the analyses. Historical versions and their dates remain part of the record.

Conditions
Tracheostomy
Being tested
Tracheostomy
Keywords
Tracheostomy, Intensive care unit, Mechanical ventilation, Multidisciplinary decision-making, Point-prevalence study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TracheostomyProcedure or surgery

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

Study groups in NCT07404592
Study groupRoleWhat they receive
Tracheostomy PatientsAdults 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.
Receives: Procedure: Tracheostomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (5)
  1. Total intubation-to-tracheostomy interval (days)

    Median and interquartile range of the total number of days between endotracheal intubation and tracheostomy among the 42 current-admission patients, overall and descriptively by recorded physician-reported reason category. The initial recommendation, intended procedure, clinical readiness and family discussion/agreement dates were unavailable. The measured interval is not decision-to-procedure time and cannot quantify days caused by a reported reason. The revised presentation is descriptive; no early-versus-late threshold comparison or timing-effect inference is retained.

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

  2. Distribution of tracheostomy techniques

    Numbers and percentages of surgical and percutaneous tracheostomies among the 42 patients with a tracheostomy established during the current admission. Percutaneous procedures are described as Griggs guidewire dilating forceps or Ciaglia single-dilator procedures. Technique was selected in clinical care, not assigned by investigators. This outcome describes procedural distribution, not comparative effectiveness or safety.

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

  3. Recorded early and late tracheostomy complications

    Numbers and percentages of the 42 current-admission patients with recorded complications, overall and descriptively by recorded reason group. The form presented separate early- and late-complication items with prelisted event types; no seven-day boundary was communicated to respondents. Recorded early-item events were hemorrhage, subcutaneous emphysema and hypoxia/desaturation; late-item events were granuloma, stoma infection and tracheoesophageal fistula. These questionnaire categories were retained in the analysis. Individual event dates were unavailable, so classification as occurring within or after seven days cannot be verified. A patient is counted once in each applicable composite; component categories may overlap. Records were reviewed only through the index day, with unequal and unmeasured observation periods. These counts are not standardized procedure-anchored incidence rates. Reason-group summaries are exploratory; outcomes are not compared by technique.

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

  4. APACHE II score and its discrimination for 30-day mortality

    Post-completion amendment during manuscript revision: the June 2026 registry entry specified admission APACHE II discrimination for mortality using the ROC area. An exploratory ROC analysis and a data-derived cutoff appeared in an earlier manuscript version. These analyses are not retained in the revised manuscript because the small selected prevalence sample does not support a validated prediction threshold or confirmatory prognostic interpretation. Current reporting is limited to the median and interquartile range of admission APACHE II scores by recorded in-hospital death status among the 42 current-admission patients. No ROC/AUC result, optimal cutoff, hypothesis test or independent-predictor claim is made in the revised analysis. This existing entry is retained to make the change transparent; it does not represent a prospectively specified descriptive analysis.

    Measured: APACHE II assessed once at ICU admission; recorded in-hospital deaths assessed from 8 September to 8 October 2025 (30 days after the index date)

  5. Causes of death among non-survivors

    Distribution of causes of death among non-survivors.

    Measured: Up to 30 days after the index day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2026
  2. Study start8 Sep 2025
  3. Primary completion8 Oct 2025
  4. Study completion8 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
282 participants (actual)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07404592
Sponsor's protocol ID
2025/352
Acronym
IZ-TRACH
Status last verified
Oct 2026
First submitted
5 Feb 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Tracheostomy, run by Izmir City Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recorded 30-day post-index in-hospital mortality (time frame: From the index date, 8 September 2025, to the follow-up assessment on 8 October 2025 (30 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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