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临床试验/NCT06229782
NCT06229782已完成不适用

Orbital Artery Doppler Ultrasound as an Ancillary Test for Diagnosing Brain Death: a Prospective, Single Blind Comparative Study

Korgün Ökmen1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2017年1月11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
66
试验地点
1
主要终点
ODUS

研究概览

简要总结

Brain death is the irreversible loss of all activity in the brain, brainstem, and cerebellum, the part of the central nervous system that remains inside the skull.

The clinical diagnosis of brain death should be supported by ancillary tests that provide information about cerebral blood flow or electrical activity in the brain. Some of the ancillary tests that evaluate cerebral blood flow include transcranial Doppler ultrasonography (TDUS), computed tomography (CT) angiography (CTA), and catheter-based cerebral angiography.

This study hypothesized that Orbital Doppler ultrasonography (ODUS) alone is more effective than TDUS in detecting intracranial blood flow in diagnosing brain death. To this end, the investigators examined the results of ODUS in patients diagnosed as brain dead who underwent CT angiography.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • suspected brain death

排除标准

  • eye surgery,
  • uncontrolled diabetes mellitus,
  • facial trauma,
  • hypothermia,
  • hypotension (systolic pressure < 100 mm Hg)
  • endocrine-metabolic coma

结局指标

主要结局

ODUS

时间窗: 30 minutes

Orbital artery Doppler ultrasound (ODUS) ODUS measurements: T1; when brain death testing started; T2; 12 hours after the first measurement, T3; before CT angiography, T4; after CT angiography Peak systolic velocity (PSV) cm/s , end-diastolic velocity (EDV) cm/s measurement results. The absence of diastolic flow, reverse diastolic flow (oscillatory flow), and resistive index \>1 were considered brain death.

Resistive index (RI)

时间窗: 30 minutes

The resistive index (RI) is a calculated flow parameter in ultrasound, derived from the maximum, minimum, and mean Doppler frequency shifts during a defined cardiac cycle. Along with the pulsatility index (PI), it is typically used to assess the resistance in a pulsatile vascular system.resistive index \>1 were considered brain death. RI measurements: T1; when brain death testing started; T2; 12 hours after the first measurement, T3; before CT angiography, T4; after CT angiography . RI = (PSV - EDV) / PSV PSV = peak systolic velocity and EDV = end-diastolic velocity.

次要结局

  • Transcranial Doppler ultrasound (TDUS)(30 minutes)
  • Cerebral blood flow (CTA)(40 minutes)
  • Optic nerve diameter(30 minutes)

研究者

发起方
Korgün Ökmen
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Korgün Ökmen

Principal Investigator

Bursa Yüksek İhtisas Education and Research Hospital

研究点 (1)

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