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临床试验/NCT05561231
NCT05561231已完成不适用

A Prospective Single Blinded Randomised Controlled Trial to Compare Endotracheal Intubation Using C Blade and D Blade of CMAC Videolaryngoscope in Patients Undergoing Elective Cervical Spine Surgery

King Edward Memorial Hospital, Mumbai2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2018年11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
68
试验地点
2
主要终点
Time taken for successful intubation

研究概览

简要总结

This study was done to compare the ease of tracheal intubation using the conventional C blade and the D blade of CMAC videolaryngoscope in patients undergoing cervical spine surgery.

详细描述

Manual in-line stabilisation is used to immobilise the neck during endotracheal intubation in patients undergoing cervical spine surgery to prevent secondary spinal cord damage. This makes visualisation of the glottis difficult with conventional laryngoscopy which can be overcome with videolaryngoscope. CMAC Videolaryngoscope has the conventional blade (C blade) and the highly angulated D blade which was introduced to aid in difficult airway. This study was done to compare the ease of tracheal intubation using the conventional C blade and the D blade of CMAC videolaryngoscope in patients undergoing cervical spine surgery.

Methodology: After Institutional Ethics Committee approval and obtaining informed consent, 68 patients undergoing elective cervical spine surgery were randomised into 2 groups - C (intubated with C blade) or D (intubated with D blade) (n=34 each) by computer generated randomisation. After induction of general anaesthesia, manual in-line stabilisation of the cervical spine was achieved and intubation was attempted by experienced anaesthesiologist with the C blade or D blade according to the group. The time taken for successful intubation, time taken for optimum glottic visualisation, the number of attempts, additional manouvres required for successful intubation and the incidence of complications were compared.

研究设计

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

入排标准

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

入选标准

  • Patients with ASA (American Society of Anaesthesiology) grade one and two,
  • aged 18 years and older,
  • Patients with mouth opening more than two and a half fingers (inter-incisor distance >3cm)

排除标准

  • Patients who were unwilling to be a part of the study,
  • patients with any oral pathology, hiatus hernia, pregnant women,
  • patients with severe systemic diseases

结局指标

主要结局

Time taken for successful intubation

时间窗: During procedure

Comparing the time taken for successful intubation using the C blade and D blade of CMAC videolaryngoscope in patients with manual in-line stabilisation of the cervical spine

次要结局

  • Time taken to obtain the best Cormack-Lehane grade(During procedure)
  • Number of attempts, external manouvres, complications(During procedure)

研究者

发起方
King Edward Memorial Hospital, Mumbai
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sandhya Narayanan P

Principle investigator

King Edward Memorial Hospital, Mumbai

研究点 (2)

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