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临床试验/NCT06018220
NCT06018220招募中不适用

Percutaneous Dilatational Tracheostomy vs. Surgical Tracheostomy in Neurocritically Ill Patients - a Retrospective Study

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 383 人开始时间: 2023年6月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
383
试验地点
1
主要终点
Number of patients with complications following tracheostomy

研究概览

简要总结

The aim of the present quality study is to examine the relationship between choice of tracheotomy procedure and complications in a neurocritically ill patient population at a single center. Secondary outcomes are the influence of clinician skill level (for PDTs), time from admission to tracheostomy, length of stay and time to decannulation.

详细描述

Neurocritically ill patients often require placement of a tracheostomy at some point during admission, as impaired consciousness and insufficient protective airway reflexes often make weaning from mechanical ventilation prolonged.

Percutaneous dilatational tracheostomy (PDT) with fiberoptic visualization can be performed bedside by neurointensivists or residents under supervision, unless there are contraindications. However, concerns regarding tracheal stenosis following PDT have been raised. This a rare complication but when it occurs it is a severe long-term complication, and the patients are often in need of repeated interventions. The alternative is surgical tracheostomy (ST) which is more resource intensive but perceived as safer in high risk patients. The indication for tracheostomy (and the choice of procedure) is ultimately based on judgement of clinical team.

Systematic reviews have found no difference between PDT and ST regarding severe complications, apart from a higher incidence of wound infections after ST. However, a higher incidence of complications following PDT has been reported when residents are performing the procedure, suggesting an influence of physician skill level.

Methods:

This is a retrospective observational single-center quality study. All patients > 18 years of age admitted to the Neurointensive Care Unit at Rigshospitalet, Copenhagen between January 2018 and December 2022 with a registered procedure code for either PDT or ST wil be included. Approval from departmental leadership and The Judicial Department at Rigshopitalet has been attained. Data will be extracted from the electronical medical records and any short (< 1 week) or long-term complications will be registered. The follow-up period is 6 months.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Patients admitted to Neurointensive Care Unit, Rigshospitalet, Denmark AND having a tracheostomy performed during their stay.

排除标准

  • Children - age < 18.

结局指标

主要结局

Number of patients with complications following tracheostomy

时间窗: Up to 1 week after tracheostomy procedure

Bleeding; pneumothorax, pneumomediastinum, lost airway, via falsa, procedure-related death, other.

Number of patients with complications following tracheostomy - long term.

时间窗: From 1 week up to 6 months after the tracheostomy procedure

Tracheal stenosis, fistula, wound infection, accidental decannulation, scarring, delayed wound healing, changes in voice or speech, other.

次要结局

  • Days(Up to 6 months)
  • Number of complications according to the skilled level of the clinician performing the tracheostomy (only for percutaneous dilatational tracheostomy)(Up to 6 months following tracheostomy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Birgitte Majholm

Principal Investigator

Rigshospitalet, Denmark

研究点 (1)

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