跳至主要内容
临床试验/CTRI/2023/03/050964
CTRI/2023/03/050964尚未招募不适用

Medical Diagnosis, Triage and Monitoring of Effect of RN Exposure and Associated Traumatic Injury

INMAS - Defence Research and Development Organisation1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2023年1月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
142
试验地点
1
主要终点
Clinical Parameters Sensitivity, Specificity and Accuracy of the novel mNIRS (CEREBO) to detect traumatic intracranial hemorrhages in suspected head injury cases

研究概览

简要总结

Traumatic Brain Injury (TBI) is a potentially fatal and debilitating condition that can cause long-term physical and cognitive impairments even if the patient survives. The prognosis deteriorates significantly with time, thus early detection and timely intervention is essential. Current clinical diagnostic tools are insufficient and there is an increasing need for a quick, accurate, and affordable computer-aided method that can collect the features of hematoma and provide early diagnosis.

The novel mNIRS is a triaging tool that detects traumatic intracranial hemorrhage objectively. The present study evaluates its performance by clinically estimating its efficacy in detecting the intractranial hemorrhage in comparison to the head CT scans

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Participants with a suspected head injury and referred for a head CT scan.

排除标准

  • Major scalp laceration, active bleeding, significant extracranial hematoma or skull abnormality, or any other condition that would not allow device placement, participants with a history of brain surgery or neurologic disease and pregnant women.

结局指标

主要结局

Clinical Parameters Sensitivity, Specificity and Accuracy of the novel mNIRS (CEREBO) to detect traumatic intracranial hemorrhages in suspected head injury cases

时间窗: 3 years

次要结局

  • To identify the design refinements for better usability for defence deployment(3 years)

研究者

发起方
INMAS - Defence Research and Development Organisation
申办方类型
Research institution

研究点 (1)

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