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临床试验/CTRI/2018/07/015108
CTRI/2018/07/015108招募中Unknown

Comparison of videolaryngoscope versus intubating laryngeal mask airway for tracheal intubation with manual in-line stabilisation in patients undergoing cervical spine surgery.

Vardhman Mahavir Medical College And Safdarjung Hospital New Delhi1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2018年1月20日最近更新:

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
66
试验地点
1
主要终点
1 Total time taken to secure the airway with tracheal tube

研究概览

简要总结

1)To compare the success of intubation using videoolaryngoscope and intubating laryngeal mask airway with manual in-line stabilisation undergoing elective surgery in terms of -Total time taken to secure the airway, number of attempts of intubation and apnea time.

2)To measure the degree of head movement during intubation.

  1. To measure the hemodynamic parameters and desaturation at baseline, before induction, after induction, every minute during procedure and thrn 1,3,5 mins after intubation.

  2. To record any mucosal injury or dental trauma in post-operative period.

HYPOTHESIS- CMAC Videolaryngoscope provides better intubating conditions as compared to Intubating laryngeal mask airway for tracheal intubation with manual in-line stabilisation.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1 ASA GRADE 1,2,3 2 Patients undergoing elective cervical spine surgery requiring tracheal intubation with manual in-line stabilisation under general anaesthesia.

排除标准

  • Patients with anticipated difficult airwayas per the following criteria- 1 Mallampati grade 4 2 Neck circumference > 40 cm 3 Mouth opening < 4 cm 4 Upper lip bite test- class 2 and
  • Any sweeling pathology in the oral cavity or around the neck.

结局指标

主要结局

1 Total time taken to secure the airway with tracheal tube

时间窗: During intubation

2 Number of attempts(1 or 2)

时间窗: During intubation

3 Apnea time

时间窗: During intubation

次要结局

  • 1 Degree of head movement(2 Haemodynamic parameters)

研究者

发起方
Vardhman Mahavir Medical College And Safdarjung Hospital New Delhi
申办方类型
Government medical college

研究点 (1)

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