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Completed

NCT Number: NCT07404592

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

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.

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Key information

Conditions

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

Design and populations This was a multicenter point-prevalence survey on 8 September 2025 with a subsequent mortality assessment on 8 October 2025. The census included all 282 adults present in eleven participating ICUs across six hospitals. Forty-six had an established tracheostomy and contribute to the point-prevalence numerator. During manuscript revision, the main descriptive sample was restricted to the 42 patients whose tracheostomy was established during the current admission. Four patients with tracheostomies created before admission remain in the census and prevalence counts but are excluded from patient-level summaries of indications, technique, postponement, complications and outcomes. Patients who died or left the ICU before the index day and patients who had not undergone tracheostomy are absent from the main sample.

Physician-reported reasons and intervals Primary treating physicians reported reasons for performing tracheostomy later than the ICU team intended. Recorded categories were a family-related reason, hemodynamic instability, awaiting surgical eligibility and bleeding diathesis. A family-related reason described the physician's report of additional deliberation or agreement after discussion with relatives or a surrogate decision-maker; it does not establish inappropriate family conduct or avoidable delay. No patient had more than one reason reported. Multiple reasons would have been recorded if reported; investigators did not choose a predominant reason from several reported reasons. No reported reason does not establish that no postponement occurred. 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.

Complications and mortality Complications were identified retrospectively from existing records through the index day. Early and late categories followed the data dictionary (within 7 days and after 7 days of tracheostomy, respectively). Individual event dates and uniform procedure-based observation periods were unavailable. Mortality was assessed over 30 days from 8 September to 8 October 2025 using local records and the hospital information system. This is post-index in-hospital mortality, not mortality within 30 days of tracheostomy or ICU admission. Individual calendar death dates and discharge/transfer indicators were unavailable in the available analysis dataset. Procedure-to-death intervals are described only among decedents; corresponding procedure-to-censoring intervals for survivors are unavailable.

Analysis and revision status The revised analyses use counts and percentages with explicit denominators and medians with interquartile ranges. Patient-level summaries use the 42 current-admission patients. Outcome summaries for family-related reasons, no reported reason, and other physician-reported reasons are post hoc and exploratory. Admission APACHE II scores are summarized by vital status; outcomes by technique are descriptive. No hypothesis tests, adjusted comparisons, causal effects or equivalence claims are presented in the revised manuscript. Earlier ROC/cutoff and early-versus-late timing analyses are not retained after methodological review. The APACHE II outcome entry below documents this change explicitly.

Registration chronology The study was completed on 8 October 2025. Its initial registry submission was on 5 February 2026 and first posting on 11 February 2026. That entry stated actual enrollment of 30 tracheostomy patients in seven ICUs and listed mortality within 30 days after tracheostomy as its only structured outcome. The authors confirm that the initial data compilation omitted data from additional ICUs within one participating center. These data were subsequently incorporated, and the analyses were rerun using the expanded dataset. An amendment submitted on 16 June 2026 and posted on 22 June 2026 changed the enrollment field to the 282-patient census, described eleven ICUs in six hospitals and the 46-patient tracheostomy subgroup, changed the mortality anchor to the index date, and added other structured outcomes. The current public registry version already describes this 282-person census and the 46-patient tracheostomy subgroup; the 30-patient/seven-ICU description belongs to the initial historical version. The change from 30 to 282 also changes the population represented by the enrollment field, from a tracheostomy subgroup to the full ICU census; it should not be interpreted solely as an increase in the number of tracheostomy patients. This present update documents clarifications and descriptive analysis changes adopted during manuscript revision after study completion. These entries do not establish prospective specification. Historical versions and their dates remain part of the public record.

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. 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)

    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.

  2. Point-prevalence of tracheostomy and physician-reported reasons for postponement

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

    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.

Secondary outcomes

  1. Total intubation-to-tracheostomy interval (days)

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

    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.

  2. Distribution of tracheostomy techniques

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

    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.

  3. Recorded early and late tracheostomy complications

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

    Numbers and percentages of the 42 current-admission patients with recorded early or late complications, overall and descriptively by technique and recorded reason group. Early categories are hemorrhage, subcutaneous emphysema and hypoxia/desaturation within 7 days of tracheostomy; late categories are granuloma, stoma infection and tracheoesophageal fistula after 7 days. A patient is counted once in each applicable composite; component categories may overlap. Records were reviewed only through the index day. Individual event dates and uniform procedure-based observation periods were unavailable. These findings are not uniform-follow-up incidence rates or valid technique-safety comparisons; reason-group summaries are post hoc.

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

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

    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 vital 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.

  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
Sep 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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