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临床试验/NCT07404592
NCT07404592已完成不适用

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

Izmir City Hospital1 个研究点 分布在 1 个国家目标入组 282 人开始时间: 2025年9月8日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
282
试验地点
1
主要终点
30-day in-hospital mortality from the index date

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Patients younger than 18 years

研究组 & 干预措施

Tracheostomy Patients

Adult patients (aged ≥18 years) hospitalized in intensive care units who have undergone either surgical or percutaneous tracheostomy.

干预措施: Tracheostomy (Procedure)

结局指标

主要结局

30-day in-hospital mortality from the index date

时间窗: 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.

Point-prevalence of tracheostomy and documented reasons for postponement

时间窗: 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).

30-day mortality

时间窗: 30 days post-procedure

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

次要结局

  • Intubation-to-tracheostomy interval (days)(From endotracheal intubation to tracheostomy, assessed through Day 1)
  • Distribution of tracheostomy technique (surgical vs percutaneous)(Day 1)
  • Early and late complication rates by technique(From tracheostomy through Day 1)
  • APACHE II score and its discrimination for 30-day mortality(Up to 30 days after the index day)
  • Causes of death among non-survivors(Up to 30 days after the index day)

研究者

发起方
Izmir City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Murat Kaykaç

Anesthesiology and Reanimation Specialist, MD

Izmir City Hospital

研究点 (1)

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