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临床试验/CTRI/2017/10/010240
CTRI/2017/10/010240已完成不适用

Comparative evaluation of three supraglottic airway devices: ILMA(Intubating Laryngeal Mask Airway),I-Gel and Ambu AuraGain for blind tracheal intubation in adults.

Lok Nayak Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年1月12日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Successful intubation in first attempt

研究概览

简要总结

Title- Comparative evaluation of three supraglottic airway devices: intubating laryngeal mask airway (ILMA), I-gel and Ambu AuraGain for blind tracheal intubation in adults. Background- Although fibreoptic endoscopy is the method of choice for tracheal intubation through a supraglottic airway device (SAD), a fibrescope may not always be available. Hence, there is need to evaluate the SADs for blind tracheal intubation through these. Our study assesses three supraglottic airway devices, intubating laryngeal mask airway (ILMA), i-gel and Ambu AuraGain for blind tracheal intubation in adults Materials and methods- After taking instituitional review board approval, this prospective randomised study was conducted in the department o f anesthesiology, MAMC and associated Lok Nayak Hospital, New Delhi. Ninety adults undergoing elective surgery under general anaesthesia was randomised into three equal groups. After a standardised induction of anesthesia, the group specific SAD was inserted and on achieving adequate ventilation with the device, blind tracheal intubation was attempted. Success rates of blind tracheal intubation through the SADs, ease of device and ET tube insertion and post operative complications (secondary outcome criteria) were evaluated. Data were analysed using SPSS version 17.0 and p<0.05 was considered statistically significant. Results- There was no difference in the incidence of adequate ventilation with any of the SAD. The success rate of tracheal intubation in 1st attempt was 86.67% in ILMA group and 26.67% in i-gel group. The success rate of tracheal intubation was 100% in ILMA group and 40% in i-gel group after both the attempts. It was not possible to intubate through Ambu auraGain in both attempts. Time taken for successful tracheal intubation in ILMA and i-gel did not differ significantly (p value=0.205). Post operative complications also did not differ significantly in the three groups. Conclusion- Out of the three, ILMA is the best device for blind tracheal intubation.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Not Applicable

入排标准

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

入选标准

  • 18-65yrs age; ASA1,2,3; Mallampalli class 1-2; thyromental distance more than 6cm; inter incisor gap more than 3cm; range of neck movement more than 90degree; Bmi less than 30kg/m2.

排除标准

  • Pregnant patients; congenital or acquired airway abnormality; patients with increased risk of aspiration; patients with GERD.

结局指标

主要结局

Successful intubation in first attempt

时间窗: All successful blind intubation after 1 attempt

次要结局

  • Overall successful intubation in two attempts(All successful blind intubation after 2 attempts)
  • Ease of insertion of device and endotracheal tube(After successful insertion of device and endotracheal tube)
  • Time of insertion in successful attempt(Time required for successful intubation in 1st or 2nd attempt)
  • Post operative complications(post operatively after 2 hours and 24 hours)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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