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临床试验/NCT02410928
NCT02410928已完成不适用

Comparison of the Vocal Cord Imaging Techniques After Thyroidectomy

Diskapi Teaching and Research Hospital1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2015年4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
75
试验地点
1
主要终点
visualisation of the vocal cords

研究概览

简要总结

Recurrent nerve palsy is a complication of thyroidectomy. Most surgeons want to visualize the vocal cords after tyroidectomy. The aim is to compare the direct laringoscopy, videolaringoscopy, fiberoptic laringoscopy and ultrasonography methods in terms of efficacy, duration and hemodynamic responses during the procedure.

详细描述

The vocal cord will be visualised after the extubation with one of the following methods:

direct laringoscopy videolaringoscopy fiberoptic laringoscopy ultrasonography The of efficacy of the method (0= not able to visualize the vocal cords, 1= the vocal cords were visualized) duration of the procedure and hemodynamic responses (heart rate, mean arterial pressure) during the procedure will be compared between the groups.

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
None

入排标准

年龄范围
19 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Benign or malignant thyroid pathology

排除标准

  • •anticipated difficult intubation

研究组 & 干预措施

fiberoptic nasal laringoscopy

Experimental

the vocal cords ill be visualized with fiberoptic nasal laringoscopy

干预措施: fiberoptic nasal laringoscopy (Device)

ultrasonography

Experimental

the vocal cords ill be visualized with ultrasonography

干预措施: ultrasonograph (Device)

Direct laringoscopy

Active Comparator

the vocal cords ill be visualized with direct laringoscopy

干预措施: direct laringoscopy (Device)

结局指标

主要结局

visualisation of the vocal cords

时间窗: 1 min after extubation

the vocal cords will be examined after extubation

duration of the procedure

时间窗: 10 min after extubation

the duration of the vocal cord examination

mean arterial pressure

时间窗: 10 min after extubation

the mean arterial pressure will be measured after extubation

heart rate

时间窗: 10 min after extubation

the heart rate will be measured after extubation

peripheal oxygen saturation

时间窗: 10 min after extubation

the peripheal oxygen saturation will be measured after extubation

次要结局

  • hypertention(5 minutes after the extubation)
  • tachycardia(5 minutes after the extubation)
  • laceration(5 minutes after the extubation)
  • teeht damage(5 minutes after the extubation)

研究者

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

DILEK YAZICIOGLU

DR

Diskapi Teaching and Research Hospital

研究点 (1)

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