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临床试验/CTRI/2022/12/047958
CTRI/2022/12/047958尚未招募不适用

A randomized controlled trial to compare the BlockBusterTM Laryngeal Mask with LMA® ProtectorTM Airway as a conduit for blind endotracheal intubation in patients undergoing elective surgery under general anaesthesia

Departmen of Anaesthesia,Lady hardinge medical college1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2022年10月12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
130
试验地点
1
主要终点
The proportion of patients having successful blind endotracheal intubation through BlockBuster™ Laryngeal Mask or through LMA® Protector™ Airway in the first attempt.

研究概览

简要总结

The supraglottic airways (SGA) are frequently used as the primary device to secure the airway in elective surgeries as well as in recognized difficult airway cases. The SGA can also be used as a rescue device, for restoring oxygenation and ventilation while allowing time to prepare for other airway manoeuvres. The SGAs can also be used as a conduit for tracheal intubation, this technique has been recommended by the Difficult Airway Society (DAS) for difficult airway management . Intubation through these devices is also recommended in the ‘All India Difficult Airway Association’ guidelines . It is also recommended that the intubation through SGAs be done under fibreoptic bronchoscope (FOB) guidance. However, this requires the availability of a FOB and expertise in its use, which may not be possible many times, particularly in the emergency situations managed by residents. Therefore, the new SGAs designed to facilitate blind tracheal intubation are gaining popularity as a bridge connecting ventilation and intubation in all genres of patients.

The BlockBusterâ„¢Laryngeal Mask, invented by professor Ming Tian in 2012 has been recently launched in the Indian market and is designed primarily to provide a green channel for the smooth passage of cuffed tracheal tube for blind tracheal intubation .

The Laryngeal Mask Airway® (LMA) Protectorâ„¢ Airway (Teleflex Medical Europe, Westmeath, Ireland) was first used in clinical practice in 2015. It is made of medical-grade silicone with two large volume gastric drainage channels and integrated with a cuff pressure indicator, the Cuff Pilotâ„¢ . The easy insertion is attributed to its fixed-curved structure, and its wide internal airway lumen diameter (up to 13 mm) which allows flexibility and thereby enhancing its use as an intubation conduit.

Blind intubation through an SGA can be lifesaving in cases of difficult airway. The technique should however be perfected first in patients with normal airways. Considering the limited availability of FOB in emergency situations, the new SGAs designed to facilitate blind tracheal intubation like the BlockBusterTM Laryngeal Mask and LMA® ProtectorTM Airway are gaining popularity. There is very limited published data comparing the first pass success rate of blind endotracheal intubation through the BlockBusterTM Laryngeal Mask with LMA® ProtectorTM Airway in patients undergoing elective surgery under general anaesthesia. Therefore, we planned this study to compare the first pass success rate of blind endotracheal intubation through both these devices. The ease, number of attempts and time taken for the placement of SGA, number of attempts, manoeuvres required and time taken to intubate through the SGA and complications will also be compared using the BlockBusterTM Laryngeal Mask with LMA® ProtectorTM Airway.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing elective surgery under general anaesthesia and requiring endotracheal intubation.

排除标准

  • 1.Anticipated difficult airway 2.Upper respiratory tract infection and severe pulmonary disease 3.BMI > 35 Kg/m2 4.Mouth opening < 2 cm 5.Risk of regurgitation and aspiration (GERD, hiatus hernia, non fasting status) 6.Pregnancy.

结局指标

主要结局

The proportion of patients having successful blind endotracheal intubation through BlockBuster™ Laryngeal Mask or through LMA® Protector™ Airway in the first attempt.

时间窗: From induction of general anaesthesia to 4 hours post operative period

次要结局

  • Proportion of patients with successful SGA placement(Mean time for placement of SGA)

研究者

发起方
Departmen of Anaesthesia,Lady hardinge medical college
申办方类型
Government medical college

研究点 (1)

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