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临床试验/ACTRN12621001384842
ACTRN12621001384842已完成未知

Tracheostomy fenestration in patients with head and neck cancer: Does it increase upper airway flow?

Royal Adelaide Hospital ENT department0 个研究点目标入组 28 人开始时间: 2021年10月14日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
28

研究概览

简要总结

  1. Research question The aim of the study was to determine if tracheostomy fenestration provided a patient with additional airflow when their tracheostomy was corked prior to decannulation, compared with a tube without fenestration. That is, did the reward of additional airflow justify the risk of harm (from malposition). 2. Background information Fenestrated tracheostomy tubes may provide additional airflow when a tube is corked, which may aid decannulation. However, fenestrated tracheostomy tubes have a higher morbidity profile than non fenestrated tracheostomy tubes as there is a risk of malposition against the tracheal wall. 3. Participant characteristics 28 participants, majority male (n=20, 71%). Median age 60 (IQR 18.6) Median height 172 (IQR 14) and BMI 24.3 (IQR 7.8). Population: Head and Neck surgical tracheostomised patients 4. Key results Of 28 participants, there was no significant difference in airflow measures (peak expiratory flow, forced expiratory volume in 1 second, maximum phonation time) between fenestrated and non fenestrated conditions. Further, 71% experienced malposition of the fenestration against the posterior tracheal wall (90% malposition with males, 25% malposition with females). 5. Limitations Given the majority of patients experienced malposition of the fenestration, this may have confounded results assessing the airflow characteristics of the fenestration.

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Any adult patient with Head and Neck cancer who has an uncuffed fenestrated tracheostomy in-situ, and who is able to tolerate corking (that is, prolonged occlusion of the tracheostomy tube via a cork or cap).

排除标准

  • Patients unable to tolerate corking (prolonged tube occlusion)
  • Patients unable to participate in spirometry due to inadequate lip seal
  • Moribund patients, unlikely to survive hospital admission
  • Patients with cognitive impairment who are unable to consent or follow instructions

研究者

发起方
Royal Adelaide Hospital ENT department

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