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临床试验/CTRI/2019/01/017143
CTRI/2019/01/017143尚未招募不适用

A Randomized controlled study on ease of nasotracheal intubation comparing Truview laryngoscope and C-MAC video laryngoscope in a simulated cervical spine immobilization

SRM Medical College Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1.Visualization of the glottic structures-Cormack Lehane grading

研究概览

简要总结

After Institutional Ethical Committee approval, 100 patients will be enrolled ion the study. Patients will be allotted into two groups(Group C for CMAC and Group T for Truview). All the patients will be premeditated with glycopyrrolate 4mcg/kg, midazolam 10mcg/kg , ondansetron 0.15mg/kg, fentanyl 2mg/kg. Patients will be induced with propofol 2mg/kg and neuro muscular blocking agent vecuronium 0.1mg/kg. Patients will be ventilated with oxygen and nitrous oxide (1:1 ratio) and sevoflurane 2% for initial 4mins, followed by ventilation with 100% oxygen for 1 mins before intubation. Manual inline stabilisation will be applied by the investigator to simulate difficult intubation scenario and the patients will be intubated nasotracheally using either of the laryngoscope. Time taken for intubation will be noted. Patients will be followed up for 24hrs post extubation.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • ASA grade I-II .
  • Mallampatti class 1&2 Surgery done under general anaesthesia requiring nasotracheal intubation.

排除标准

  • Patients who refuse the study Patient with known allergies to the study drugs ASA>2, Mallampatti class 3&4 Difficult airway Emergency procedures Pregnancy Patients with coagulation abnormalities.
  • Patients with fractures involving base of skull.

结局指标

主要结局

1.Visualization of the glottic structures-Cormack Lehane grading

时间窗: Time in seconds from inserting the laryngoscope into the oral cavity to visual confirmation of tracheal tube passing through the glottic aperture.

2. Ease of intubation.

时间窗: Time in seconds from inserting the laryngoscope into the oral cavity to visual confirmation of tracheal tube passing through the glottic aperture.

3. Intubation time.

时间窗: Time in seconds from inserting the laryngoscope into the oral cavity to visual confirmation of tracheal tube passing through the glottic aperture.

次要结局

  • Incidence of airway trauma(From laryngoscopy to 24hours post extubation)

研究者

发起方
SRM Medical College Hospital and Research Institute
申办方类型
Research institution and hospital

研究点 (1)

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