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临床试验/NCT04325997
NCT04325997已完成不适用

Applicaion of Mouth Opener Combined With Electronic Video Laryngoscope in Double-lumen Intubation of Patients With Difficult Airway

Zhuan Zhang1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Glottis exposure time

研究概览

简要总结

How to quickly expose glottis and accurately insert double luminal tracheal tube in patients with difficult airway in thoracoscopic surgery has become an urgent problem in anesthesia induction.This study through the double cavity bronchial tube visual laryngoscope intubation with open mouth and electronic video laryngoscope used in combination, to explore whether can shorten the glottis exposure, improve the success rate of the double lumen tube intubation will reduce pharyngeal damage, reduce intubation hemodynamic fluctuations, in order to improve the glottis appeared difficult patients with bronchial intubation success rate to provide the reference.

详细描述

A total of 60 patients who needed double-lumen endobronchial catheterization in thoracic department and whose Arne o 'risk index score was at least 7 points were randomly divided into three groups.Group B was intubated with video laryngoscopy.Group C was intubated with a mouth opener for video laryngoscope combined with a double-lumen bronchial tube for video laryngoscope intubation (hereinafter referred to as the mouth opener).The glottis exposure time, bronchial intubation time, intubation times, success rate of one intubation, and NRS score of pharyngeal pain 8 hours after surgery were observed and recorded in the three groups, and the hemodynamic changes after intubation were observed and recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of early lung cancer
  • Ages ranged from 30 to 80

排除标准

  • Pregnancy
  • Prediction of difficulty in mask ventilation
  • Chest X-ray examination of trachea, bronchial anatomical abnormalities or tumor compression caused by trachea/bronchial deformation
  • Failure of assessing Arne risk index

结局指标

主要结局

Glottis exposure time

时间窗: through study completion, an average of 1 minute

One-time success rate of intubation

时间窗: through study completion,an average of 1 minute

Bronchial intubation time

时间窗: through study completion,an average of 1 minute

The number of intubation

时间窗: through study completion,an average of 1 minute

Glottic field grading

时间窗: through study completion,an average of 1 minute

Cormack-Lehane grading, C-L1:Can see glottis mostly;C-L2:Only the posterior union of the glottis is visible, not the glottis, and at most the cartilago arytaenoidea is visible when the larynx is lightly pressed;C-L3: can't see any part of the glottis, only the epiglottis; C-L4:No part of the larynx can be seen

次要结局

未报告次要终点

研究者

发起方
Zhuan Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhuan Zhang

Clinical Professor

Yangzhou University

研究点 (1)

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