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临床试验/NCT03747250
NCT03747250已完成不适用

Videolaryngoscopy Versus Direct Laryngoscopy for Elective Airway Management in Pediatric Anesthesia: Randomized Controlled Trial

Brno University Hospital2 个研究点 分布在 1 个国家目标入组 501 人开始时间: 2019年1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
501
试验地点
2
主要终点
First intubation attempt success rate

研究概览

简要总结

Videolaryngoscopy can lead to superior airway conditions and to the possible higher success compared to standard direct laryngoscopy. Patient will be randomized to the interventional group (videolaryngoscopy) and control group (direct laryngoscopy). The first attempt success rate, time to first end-tidal CO2 (ETCO2) wave, overall success rate, incidence of aspiration, bradycardia, desaturation a overall complications will be monitored.

详细描述

Videolaryngoscopy is specialized equipment for airway management, where a camera located at the tip of the laryngoscope blade can visualize also structures that can´t be seen on direct laryngoscopy, co the operator can obtain superior view of aditus laryngis during intubation. Currently videolaryngoscopy is not routinely used for intubation and it is reserved for patients with difficult airway. The aim of the trial is to compare the elective use of videolaryngoscopy versus direct laryngoscopy for elective airway management (tracheal intubation). Patients after informed consent approval will be randomized to the interventional group (videolaryngoscopy) and control group (laryngoscopy). The randomization will be managed by the Institute of Biostatistics and Analyses by the Faculty of medicine, Masaryk university. The primary aim will be the first intubation attempt success rate, the secondary aims will be time to successful intubation (time to first ETCO2 wave), overall success rate, number of intubation attempts, incidence of aspiration, desaturation and incidence of overall complications in all operators, in trainees, residents (5-10 years of practice), consultants (10-15 years of clinical practice) and consultants with over 15 years of clinical practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

The allocation to the group will be randomized in located in closed envelope, that will be opened in the operating theater before anesthesia induction

入排标准

年龄范围
29 Days 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients scheduled for elective surgery
  • Planned tracheal intubation for airway management during surgery
  • Signed informed consent

排除标准

  • Emergency surgery
  • Other airway management plan
  • age outside the predefined limits
  • Informed consent not signed

结局指标

主要结局

First intubation attempt success rate

时间窗: Intraoperatively

Success rate of the first intubation attempt

次要结局

  • Laryngeal view(Intraoperatively)
  • Complications(Intraoperatively)
  • Overall intubation success rate(Intraoperatively)
  • Time for successful intubation(Intraoperatively)

研究者

发起方
Brno University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Petr Štourač, MD

assoc.prof.MD,Ph.D

Brno University Hospital

研究点 (2)

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