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临床试验/NCT03984981
NCT03984981已完成不适用

Brain Death Diagnosis at an Academic Tertiary Medical Care Center

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年4月3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
100
试验地点
1
主要终点
adherence to the local brain death protocol ( = measurement tool) for the process of brain death diagnosis

研究概览

简要总结

The aim of this study is to assess and survey the quality of the process required to diagnose brain death in adult patients. This study of adult patients diagnosed brain dead or suspected of having brain death on the ICUs at the University Hospital Basel will be purely observational.

研究设计

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

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

  • patients with suspected and/or diagnosed brain death
  • adults 18 years and over

排除标准

  • 未提供

结局指标

主要结局

adherence to the local brain death protocol ( = measurement tool) for the process of brain death diagnosis

时间窗: single time point assessment at baseline (after suspected brain death)

the local brain death protocol ( = measurement tool) requires 1.) exclusion of the following conditions: * shock (mean arterial blood pressure \> 60 mmHg, lactate \< 4 mmol/l) * hypothermia (temperature \> 35°C) * severe acidosis (pH \> 7.3) * hyperosmolarity (osmolarity \< 320 mmol/l) * severe electrolyte disorders (sodium \> 125 mmol/l, phosphate \> 0.3 mmol/l) * hypoglycemia (glucose \> 4 mmol/l) * hyperammonemia (ammonia \< 60 mumol/l) * uremia (urea \< 25 mmol/l) * prolonged effects of medication (muscle relaxants, sedatives, recreational drugs) * severe hypothyreosis 2.) clinical examination confirming: * fixed pupils (dilated or mid-dilated bilaterally) * absent vestibulo-ocular reflex * absent corneal reflex bilaterally * no reaction to painful stimulus bilaterally * absence of cough and gag reflex * absence of spontaneous breathing (apnea test)

次要结局

  • number of physicians involved(single time point assessment at baseline (after suspected brain death))
  • frequency of ancillary tests performed(single time point assessment at baseline (after suspected brain death))
  • number of work-ups excluding suspected brain death(single time point assessment at baseline (after suspected brain death))
  • number of diagnostic work-ups with insufficient performance and/or documentation(single time point assessment at baseline (after suspected brain death))
  • years of clinical experience of physicians involved(single time point assessment at baseline (after suspected brain death))

研究者

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

研究点 (1)

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