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临床试验/CTRI/2014/01/004275
CTRI/2014/01/004275已完成不适用

A comparison of left molar macintosh laryngoscope with gum elastic bougie and Bonfils intubation fiberscope for tracheal intubation in patients with simulated restricted neck mobility

ESI Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2012年10月12日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Time to intubation

研究概览

简要总结

conventional intubation techniques require movement of cervical spine to align the three axis to allow direct vision of the vocal cords. cervical collar may reduce the neck movements and mouth opening and makes larynx more anterior, thus making intubating conditions extremly challenging.  Bonfils intubation fiberscope is being increasingly used to facilitate intubation in anticipated and unanticipated difficult airways with good success rates. it has also been shown to markedly improve the intubation success in patients with cervical collar. but this device is expensive , may not be available and has a steep learning curve.

In modern era of technology direct laryngoscopy remains most readily available and fastest means of securing the airway in patients .Left molar approach to direct laryngoscopy improves the glottic view in simulated DA and may help negate the advantage of bonfils intubation fibersope. So ,we hypothetised that bougie assisted left molar approach to laryngoscopy may be a good alternative to Bonfils for intubation in patients with rigid cervical colalr for intubation.

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
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • After ethics committee approval and written informed consent, 120 ASA physical status I/II patients (18-60 years) scheduled to undergo elective surgical procedures requiring general anesthesia were prospectively included in the study.

排除标准

  • anticipated difficult ventilation or intubation (Mallampatti class 3/4, Mouth opening (MO)< 3cm, thyromental distance < 6.5 cm and sterno mental distance < 12.5 cm), patients with loose molar teeth or increased risk of aspiration, pregnant patients, obese patients (BMI >35) and those with history of difficult intubation were excluded.

结局指标

主要结局

Time to intubation

时间窗: from beginning of insertion of the device ( bonfils/ laryngoscope) till the End tidal capnograph tracing on the monitor

次要结局

  • post operative complications:x.Postoperative sore throat (mild, moderate and severe)15, dysphagia or any other respiratory morbidity(1, 6 and 24 hours.)

研究者

发起方
ESI Hospital
申办方类型
Other [Government hospital]

研究点 (1)

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