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Trakeostomipraxis på intensivvårdsavdelningar för vuxna: En multicenterstudie i Izmir (IZ-TRACH)

19 oktober 2026 uppdaterad av: Murat Kaykaç, Izmir City Hospital

TRACHEOSTOMI-PRAXIS I VUXENINTENSIVVÅRDSENHETER I IZMIR, TURKIET: EN MULTICENTR-PUNKTPREVALENSSTUDIE

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

282

Kontakter och platser

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Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: CROSS_SECTIONAL

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Recorded 30-day post-index in-hospital mortality
Tidsram: 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.

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
Tidsram: 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.

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Total intubation-to-tracheostomy interval (days)
Tidsram: 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.

From endotracheal intubation to tracheostomy, retrospectively assessed through 8 September 2025
Distribution of tracheostomy techniques
Tidsram: 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.

Tracheostomies established before and present on the index day, 8 September 2025
Recorded early and late tracheostomy complications
Tidsram: 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 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.

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
Tidsram: 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)

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.

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)
Causes of death among non-survivors
Tidsram: Up to 30 days after the index day

Distribution of causes of death among non-survivors.

Up to 30 days after the index day

Samarbetspartners och utredare

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Utredare

  • Studierektor: Murat KAYKAC, M.D., Izmir City Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

8 september 2025

Primärt slutförande (Faktisk)

8 oktober 2025

Avslutad studie (Faktisk)

8 oktober 2025

Studieregistreringsdatum

Först inskickad

5 februari 2026

Först inskickad som uppfyllde QC-kriterierna

5 februari 2026

Första postat (Faktisk)

11 februari 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

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