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临床试验/NCT07837882
NCT07837882招募中不适用

Evaluation Of Two Different Videolaryngoscopes İn A Pediatric Patient Group; Prospectus Observational Study

Samsun University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
intubation time

研究概览

简要总结

Modern alternatives to traditional laryngoscopes utilize fiber optic or digital technology to project images from the tip of the laryngoscope onto an eyepiece or monitor for improved visualization by the practitioner. Videolaryngoscopes have become an integral part of routine clinical practice and training programs, and a preferred option after failed DL (directional visualization). This study will compare two different videolaryngoscopes in pediatric participants.

详细描述

Based on current literature data, it is suggested that videolaryngoscopy should be considered as the first choice in neonates and infants and that its integration into routine pediatric anesthesia practice may be appropriate. However, it is reported that videolaryngoscopy, compared to direct laryngoscopy, can partially separate the relationship between glottic visualization quality and tracheal tube placement difficulty. Currently, there is no standardized and widely accepted classification system specific to videolaryngoscopy tracheal intubation in pediatric patients. To address this deficiency, the Pediatric Videolaryngoscopic Intubation and Difficult Airway Classification (PeDiAC) score was developed and prospectively defined and validated to determine the difficulty level of pediatric videolaryngoscopy intubation. In this study, the diagnostic performance of the PeDiAC score was evaluated in comparison with the traditionally used Cormack-Lehane classification, and its superiority was investigated. In this planned study, the primary outcome to be evaluated is intubation time, while the secondary outcome is assessed using the PeDiAC score. The aim is to compare the difficulty of intubation between the two devices based on this score. This study aims to determine whether there are differences between the two different videolaryngoscopes in terms of similar clinical outcomes.

研究设计

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

入排标准

年龄范围
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •2-10 years old
  • •Elective surgery
  • •Requirement for intubation under general anesthesia
  • •Expected normal airway

排除标准

  • •Difficult airway on preoperative assessment
  • •Need for rapid serial intubation
  • •History of previous difficult intubation
  • •Cervical instability
  • •Upper respiratory tract infection within the last 4 weeks
  • •Neuromuscular disease
  • •History of asthma

研究组 & 干预措施

group E

In this group, intubation will be performed using an Endolarenx brand videolaryngoscope.

干预措施: In this group, intubation will be performed using a Endolarenx brand videolaryngoscope (Device)

Grup B

In this group, intubation will be performed using a Besdata brand videolaryngoscope.

干预措施: In this group, intubation will be performed using a Besdata brand videolaryngoscope (Device)

结局指标

主要结局

intubation time

时间窗: 2 minutes after induction

The time elapsed from the passage of the laryngoscope blade through the teeth to the detection of end-tidal CO₂.

次要结局

  • PeDiAC Score(1 hour)
  • Cormack-Lehane glottic view scale(1 hour)
  • Successful intubation attempt(1 hour)

研究者

发起方
Samsun University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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