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临床试验/NCT03562104
NCT03562104已完成不适用

Swallowing Disorders and Consciousness Alteration in Severe Traumatic Brain Injury Patients

University Hospital, Rouen2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年11月30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
发起方
入组人数
34
试验地点
2
主要终点
Stages of swallowing disorders

研究概览

简要总结

This study aimed to characterize swallowing disorders in minimally consciousness patients after brain traumatic injury.

详细描述

After inclusion, the patients will underwent a videofluoroscopy and the Wessex Head Injury Matrix.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Legal representant signed
  • Aged between 18 and 70 years
  • Having a severe TBI (Glasgow < 8)
  • Without counterindication to underwent a VideoFluoroScopy
  • Could hold a setting position

排除标准

  • Pregnancy ongoing
  • Having a pathologic al examination of IX, X, XII cranial nerve examination
  • Massif faciale fracture
  • Psychiatric illness
  • Medical history of swallowing disorders

研究组 & 干预措施

Minimally consciousness Patient

Experimental

Wessex Head Injury Matrix scale and Videofluoroscopy for characterization of swallowing disorders in Minimally consciousness Patient

干预措施: videofluoroscopy (Other)

Minimally consciousness Patient

Experimental

Wessex Head Injury Matrix scale and Videofluoroscopy for characterization of swallowing disorders in Minimally consciousness Patient

干预措施: Wessex Head Injury Matrix scale (Other)

结局指标

主要结局

Stages of swallowing disorders

时间窗: Day 1

swallowing disorder stage is done using videofluoroscopy

次要结局

  • Correlation between Wessex Head Injury Matrix (WHIM) and stage of swallowing disorder(Day 1)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (2)

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