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临床试验/NCT04151914
NCT04151914Unknown不适用

Prevalence of Auditory Dysfunction and ICU-acquired Delirium Following Cardiac Surgery With Cardiopulmonary Bypass: a Prospective Observational Study

European Georges Pompidou Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Prevalence of auditive dysfunction following cardiac surgery with cardiopulmonary bypass

研究概览

简要总结

AUDICS-ICU is a prospective observational aiming to evaluate the prevalence of auditive dysfunction following cardiac surgery. Participants will undergo audiometric testings before and 3 months after cardiac surgery with cardiopulmonary bypass. Furthermore, the study evaluates hearing loss-associated ICU-acquired delirium after cardiac surgery with cardiopulmonary bypass.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Over 18 years old
  • Undergoing non urgent cardiac surgery with cardiopulmonary bypass

排除标准

  • History of ear surgery
  • Ear disease
  • Inadequate understanding of the protocol

结局指标

主要结局

Prevalence of auditive dysfunction following cardiac surgery with cardiopulmonary bypass

时间窗: 3 months

Change from baseline audiometric testings at 3 months after cardiac surgery with cardiopulmonary bypass

次要结局

  • Patient's quality of life after cardiac surgery: Survey(3 months)
  • ICU-acquired delirium(7 days)
  • Cerebral perfusion(7 days)

研究者

发起方
European Georges Pompidou Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthieu Daniel

Principal Investigator

European Georges Pompidou Hospital

研究点 (1)

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