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临床试验/CTRI/2021/04/033279
CTRI/2021/04/033279已完成不适用

C MAC VIDEO LARYNGOSCOPE VERSUS TUOREN VIDEO LARYNGOSCOPE FOR ENDOTRACHEAL INTUBATION IN THE PAEDIATRIC POPULATION UNDERGOING GENERAL ANAESTHESIA

Maulana Azad Medical College1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年5月5日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Intubation Difficulty Scale (IDS) score, consisting of seven parameters

研究概览

简要总结

The pediatric airway management poses a challenge to anaesthesiologists across the globe due to the major anatomical, physiological and developmental differences in them as compared to the adult population. One of the prime causes of anaesthetic morbidity and mortality is complications arising from difficult tracheal intubation despite recent evolution in airway management strategies. Direct laryngoscopy (DL) has been regarded as the gold standard for endotracheal intubation (ETI) in both paediatric and adult patients. Direct laryngoscopy guided tracheal intubation requires the three axes (oral, pharyngeal and laryngeal) to be arranged in one straight line, achieved by placing the head and neck in the sniffing position. Up to 4.7% of paediatric patients undergoing general anaesthesia (GA) may present with difficult intubation. Hence, one has to be equipped to manage a situation of difficult airway at all times.

In an attempt to reduce the morbidity and mortality associated with difficult airway, several video laryngoscopes (VLs) such as Glidescope, Truview, Airtraq and C-MAC have been introduced into clinical practice. These video laryngoscopes ensure a better glottic view, with greater intubation success and reduced complications as compared to the conventional direct laryngoscopy in the adult population, and are being increasingly used in the paediatric population. Flexible fiberoptic bronchoscopes are used in difficult pediatric airway, but are technically more challenging than the video laryngoscopes.

The C-MAC VL is a fourth generation VL, with a standard Miller/Macintosh blade with a distal camera at two-thirds of its length. It has been successfully used for visualization of the larynx in various difficult airway cases.It is available in the Macintosh blade sizes (sizes 2, 3, and 4) and pediatric Miller sizes (sizes 0 and 1). It also has a D- blade for difficult airways.

Tuoren is a newer video laryngoscope, which has advantages of disposable blades, large screen size, anti-fogging feature and a longer battery life, in addition to being portable and cost effective. It has a blade that has retained the shape and curvature of Macintosh blade. The reusable laryngoscope handle is fully compatible with 6 size of blades: Mac2/Mac3/Mac4/MIL00/MIL0/MIL1.

Hence, in this randomized comparative study, we aim to compare C Mac and Tuoren video laryngoscope guided endotracheal intubation using micro-cuffed endotracheal tube in paediatric patients undergoing elective surgery under general anaesthesia.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
2.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Patients belonging to American Society of Anaesthesiologists (ASA) Physical Grade I and II undergoing elective surgery under general anaesthesia requiring endotracheal intubation.

排除标准

  • Patients with mouth opening less than or equal to 2.5 cm
  • Patients belonging to Modified Mallampati class III and IV
  • Patients with predicted difficult airway (anatomical deformity of head and neck, fracture of maxillofacial region or tumors of oral cavity).

结局指标

主要结局

Intubation Difficulty Scale (IDS) score, consisting of seven parameters

时间窗: During laryngoscopy and endotracheal intubation

次要结局

  • Time taken to intubate(Between blade entry past the lips and the appearance of first square wave capnograph)
  • Intraoperative hemodynamic response measured by:(1.Heart rate trend in the intraoperative period)
  • Complications including:(1. Blood staining on the device or tracheal tube)

研究者

申办方类型
Government medical college

研究点 (1)

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