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临床试验/NCT02191904
NCT02191904已完成不适用

Laryngoscope Types and The Cervical Motion

Trakya University0 个研究点目标入组 150 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
主要终点
CERVICAL MOTIONS

研究概览

简要总结

To ensure minimal cervical motion during the intubation of trauma patients is important for the prevention of cervical spine injury (CSI) or further deterioration of existing CSI.

Intubation is required to secure the airway in patient during an anesthesia management or a mechanical ventilation at intensive care units. Laryngoscopes are the assisting tools for intubations. The most widely used laryngoscope type is one with a Macintosh blade. However, various types of laryngoscopes have been developed to be used for in case of difficult intubations, the intubation of the patients with head and neck trauma, or the intubation attempts carried out by inexperienced individuals. Truview EVO2® and Airtraq® are newly developed laryngoscopes, integrated with an optical view system.

The Truphatek TruView EVO2® (Truphatek International Ltd, Netanya, Israel) is a recently introduced, easy viewing type of laryngoscope, modified from the blades of Macintosh type laryngoscopes, having an angle of 46° at the end of blade and including a camera system that magnifies the image.

The Airtraq® laryngoscope (ATQ; King Medical Systems, Newark, DE) is also a newly developed type of laryngoscope, including optical imaging system. There is a channel on the device for the placement of the endotracheal tube. Endotracheal tube is inserted into the channel before the laryngoscopy. It has been reported that Airtraq is a novel single use laryngoscope which provides glottis display without any deviation in the normal position of the oral, pharyngeal or the tracheal axes.

In the literature, there are many studies comparing the effects of these newly developed laryngoscopes on cervical motions in different scenarios with cadavers and normal patients. However, in these studies, individual vertebral motion was reported during the placement of the tube, while the angulation of the head and neck and the difficulty of the intubations were not clear.

In this study our first hypothesis was cervical motion during endotracheal intubation in Truview EVO2® and Airtraq® types of laryngoscopes is lesser than Macintosh. The second one was the endotracheal intubation time is similar to the Macintosh that is used more often.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patients who will undergo general anesthesia for abdominal surgery, American Society of Anesthesiologists physical status I to III, The patients who were aged between 20 and 75

排除标准

  • Our exclusion criteria were to have a history of emergency intubation or a difficult intubation, to have a body mass index higher than 35 or a rheumatologic disease that cause limitation of cervical motion, to have a previous history of cervical operation or tumor, trauma or infection on upper airway, and to have no tooth.

结局指标

主要结局

CERVICAL MOTIONS

时间窗: January 2011 and December 2012

While the ventilation with face mask, different manupulations could be performed to the head. Therefore, neutral position was applied to the head before the laryngsocpy. In this procedure, the head was stabilized as the infraorbital edge and tragus is perpendicular to the ground. An inclinometer (A 360 degree angle gauge) was placed on the forehead of the patients, so that the tip of the inclinometer fits to glabellar line (figure 2,3). Inner diameter of the intubation tubes used for females and males were 7 to 7.5 mm and 8 to 8.5 mm, respectively. The maximum angulation were measured by an inclinometer and recorded from beginning of the laryngoscopy to the placement of the intubation tube into the trachea.

次要结局

  • Intubation Time(January 2011 and December 2012)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alkin Colak

Associate professor

Trakya University

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