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临床试验/NCT04188613
NCT04188613已完成不适用

Use of High-Frequency Jet Ventilation During Percutaneous Tracheostomy as an Alternative to a Classic Mechanical Ventilation by Endotracheal Tube

Diskapi Yildirim Beyazit Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
percutaneous tracheostomy time

研究概览

简要总结

Percutaneous tracheostomy is the mouth opening of the tracheal ostium to the skin by creating an opening in the anterior wall of the trachea using Seldinger methods. This procedure is done using an endotracheal tube (ETT) or a laryngeal mask (LMA). High-frequency jet ventilation (HFJV) commonly used in oropharyngeal surgeries and creates an extra passage for the procedure. The investigators aimed to demonstrate the effective use of HFJV in percutaneous tracheostomy.

详细描述

Seventy five patients between 18-80 years of age who were hospitalized in intensive care unit were included in the study. The number of patients will be finalized by power analysis. whose written consent cannot be obtained and who undergo surgical tracheostomy for any reason will be excluded from the study. In addition, patients with active infection in the area of the procedure, bleeding diathesis and pathologies that interfere with the procedure in the ultrasonographic evaluation (thyroid diseases, etc.) will be excluded from the study. Patients will be divided into three groups as those using classical ventilation (group 1), HFJV (group 2) and classical laryngeal mask (group 3). Age, gender, height, BMI, ASA scores, presence and type of additional diseases, tracheostomy day, pre- and post-procedure blood gas analysis, duration of procedure, duration of anesthesia, complications during the procedure (bleeding , desaturation, accidental extubation, malposition, bradycardia, hypotension, etc.) will be recorded. Patients will be observed for mortality in the first 30 days after the procedure. Mortality results will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • percutaneous tracheostomy procedure

排除标准

  • whose written consent cannot be obtained
  • who undergo surgical tracheostomy for any reason
  • patients with active infection in the area of the procedure,
  • bleeding diathesis
  • pathologies that interfere with the procedure in the ultrasonographic evaluation (thyroid diseases, etc.)

结局指标

主要结局

percutaneous tracheostomy time

时间窗: during procedure

the time the needle enters the skin to the insertion of the tracheostomy cannula

次要结局

  • complications rate(during procedure)

研究者

发起方
Diskapi Yildirim Beyazit Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Savas Altinsoy

Principal Investigator

Diskapi Yildirim Beyazit Education and Research Hospital

研究点 (1)

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