跳至主要内容
临床试验/CTRI/2024/03/063435
CTRI/2024/03/063435尚未招募不适用

NIRS in traumatic intracranial hematoma detection in traumatic head injury

Dr Dhaval Shukla1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年3月15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
150
试验地点
1
主要终点
Sensitivity, Specificity and Accuracy of NIRS device for detecting traumatic intracranial hematoma.

研究概览

简要总结

Timely identification and treatment of intracranial injuries in the elderly are vital to prevent rapid deterioration and improve outcomes. By potentially reducing diagnostic delays, CEREBO may offer substantial improvements in the standard care for elderly TBI patients, leading to better health outcomes and reduced healthcare burdens. This clinical study is designed to assess the performance of CEREBO, an intracranial injury detector, in the detection of traumatic intracranial injuries among individuals aged 65 years and older. The study will investigate the efficacy of CEREBO in a demographic with a higher risk of TBI complications. The results from CEREBO will be compared against head CT scans to determine accuracy and reliability in this specific age group. The primary aim is to improve the early detection of intracranial injuries. The study will also assess the efficacy of the NIRS device in continuous monitoring of TBI patients under conservative treatment. It will evaluate whether there exists a significant correlation between the NIRS data and the depth and volume of hematoma within the same subject.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Head injury patients visiting the hospital and are referred for a head CT scan.

排除标准

  • Major scalp laceration or active bleeding.
  • Significant extracranial hematoma.

结局指标

主要结局

Sensitivity, Specificity and Accuracy of NIRS device for detecting traumatic intracranial hematoma.

时间窗: 3 years

次要结局

  • To evaluate the NIRS based device for continuous monitoring of TBI patients under conservative treatment.(3 years)
  • Usability parameters including but not limited to ease of use, scan time, etc.(3 years)

研究者

发起方
Dr Dhaval Shukla
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Dhaval Shukla

National Institute of Mental Health and Neuro Sciences

研究点 (1)

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