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临床试验/NCT03279172
NCT03279172已完成不适用

A Comparison of Videolaryngoscope and Direct Laryngoscope in Intraocular Pressure Changes, Throat Pain, Intubation Time and Hemodynamic Variables

Diskapi Teaching and Research Hospital2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
2
主要终点
High intraorbital pressure

研究概览

简要总结

The aim of the study was to compare intraocular pressure, intubation time, throat pain and hemodynamic variables using direct or videolaryngoscopy under general anesthesia requiring endotracheal intubation

详细描述

INTRODUCTION Videolaryngoscopes are the new generation devices which were introduced into the difficult intubation algorithm by the American Society of Anaesthesiologists (ASA) in 2013 (1). Videolaryngoscopes are known to be superior to traditional direct laryngoscopy in cases of difficult airway, glottic visualisation is obtained more easily and less airway trauma is seen (2). Portable videolaryngoscope which is used in difficult airways (3). There are 2, 3, and 4 numbered blades. In the light source of the blade of the videolaryngoscope, there is a camera which is connected to a video screen monitor. In addition to passing soft tissues by visualisation, the camera is helpful in defining the glottic appearance (1).

There are studies which have compared the hemodynamic response and increase in IOP in intubation using direct laryngoscope and various videolaryngoscopes and airway devices . However, to the best of our knowledge there is no study comparing the effect on the increase in IOP of videolaryngoscope and direct laryngoscope. The aim of the current study was to compare IOP, hemodynamic parameters and throat pain in the use of videolaryngoscope and the direct laryngoscope.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective Surgery under general anaesthesia

排除标准

  • History of Glaucoma
  • History of hearth disease
  • History of Alzheimer

研究组 & 干预措施

Group Direct Laryngoscope

Experimental

direct laryngoscope (macintosh laryngoscope) is used in elective surgeries with maximal duration time for two hours. Standard anaesthesia was used on group and BIS monitorisation was applied. A record was made of IOP, hemodynamic changes and oxygen saturation at 3 and 10 minutes after intubation. Throat pain was evaluated by questioning the patient at 10 minutes and 24 hours after waking from general anaesthesia. The duration of intubation was recorded as the time from the laryngoscope entering the mouth to removal with end-tidal carbon dioxide on the monitor. Macintosh laryingoscope, BIS monitoring and tonometry would be used in Group Direct Laryngoscope.

干预措施: direct laryngoscope (Procedure)

Group Direct Laryngoscope

Experimental

direct laryngoscope (macintosh laryngoscope) is used in elective surgeries with maximal duration time for two hours. Standard anaesthesia was used on group and BIS monitorisation was applied. A record was made of IOP, hemodynamic changes and oxygen saturation at 3 and 10 minutes after intubation. Throat pain was evaluated by questioning the patient at 10 minutes and 24 hours after waking from general anaesthesia. The duration of intubation was recorded as the time from the laryngoscope entering the mouth to removal with end-tidal carbon dioxide on the monitor. Macintosh laryingoscope, BIS monitoring and tonometry would be used in Group Direct Laryngoscope.

干预措施: videolaryngoscope (Procedure)

Group videolaryngoscope

Experimental

Videolaryngoscope is used in elective surgeries with maximal duration time for two hours. Standard anaesthesia was used on group and BIS monitorisation was applied. A record was made of IOP, hemodynamic changes and oxygen saturation at 3 and 10 minutes after intubation. Throat pain was evaluated by questioning the patient at 10 minutes and 24 hours after waking from general anaesthesia. The duration of intubation was recorded as the time from the laryngoscope entering the mouth to removal with end-tidal carbon dioxide on the monitor. Video laryingoscope, BIS monitoring and tonometry would be used in Group Video Laryngoscope.

干预措施: direct laryngoscope (Procedure)

Group videolaryngoscope

Experimental

Videolaryngoscope is used in elective surgeries with maximal duration time for two hours. Standard anaesthesia was used on group and BIS monitorisation was applied. A record was made of IOP, hemodynamic changes and oxygen saturation at 3 and 10 minutes after intubation. Throat pain was evaluated by questioning the patient at 10 minutes and 24 hours after waking from general anaesthesia. The duration of intubation was recorded as the time from the laryngoscope entering the mouth to removal with end-tidal carbon dioxide on the monitor. Video laryingoscope, BIS monitoring and tonometry would be used in Group Video Laryngoscope.

干预措施: videolaryngoscope (Procedure)

结局指标

主要结局

High intraorbital pressure

时间窗: 1 minute

IOP 18-22 mmHg

次要结局

未报告次要终点

研究者

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

Ceyda Ozhan Caparlar

Principle investigator, Clinical Specialist of anesthesiology

Diskapi Teaching and Research Hospital

研究点 (2)

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