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临床试验/NCT06581705
NCT06581705已完成不适用

The C-MAC Video Laryngoscope Helps Presbyopic Anesthetists to Overcome Difficulty in Neonatal and Infantile Intubation. A Randomized Controlled Trial

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
the frequency of successful intubation

研究概览

简要总结

Endotracheal intubation is the de facto gold standard for airway management especially in neonatal and pediatric anesthesia .

An efficient neonatal airway management is challenging even in the most experienced hands and the prevalence of difficult intubation in pediatric anesthesia varied greatly on a wide range.

详细描述

Neonatal intubation is a life-saving procedure, which requires skilled operator but still may cause direct tissue trauma and precipitate adverse reactions. However, intubation with videolaryngoscope (VL) requires less force than with a direct laryngoscope to minimize the possibility of these adverse events.

The recent Brazilian recommendations for management of pediatrics difficult airways included proper assessment, preparation, positioning, pre-oxygenation, minimizing trauma, maintenance of arterial oxygenation and the implementation of the advanced tools as VL, flexible intubating bronchoscopy, and supraglottic devices.

The recent British recommendations also advised for the use VL with an age-adapted standard blade as first choice for tracheal intubation and the use of a stylet to reinforce and preshape tracheal tubes in case of the use of hyperangulated VL blades .

Considering the recent interest in assessing the performance of various VLs in pediatric anesthesia, the C-MAC® (Karl Storz, Germany) VL with standard Miller blade sizes #0 and #1, is a widely used in neonates and infants for its provision of superior-quality glottis view in comparison to the McGrathTM MAC size #1 blade and direct laryngoscopy.

Presbyopia is defined as disordered eye adjustment function and affects middle aged people leading to difficult viewing close objects and is corrected with magnifying lens.

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
None

入排标准

年龄范围
2 Months 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric Patients whom scheduled for surgical procedures under general inhalation anesthesia

排除标准

  • Patients older than 12 months
  • patients with Mallampati score of 3 or 4,
  • patients had abnormal airway and obstructive sleep apnea,
  • manifestations of upper respiratory tract infection or uncompensated cardiopulmonary diseases
  • patients with ASA grade >III were excluded from this study.

结局指标

主要结局

the frequency of successful intubation

时间窗: 30 seconds

The frequency of the need for external laryngeal manipulation, head extension, or stylet curvature change to achieve intubation

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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