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临床试验/NCT05189561
NCT05189561已完成不适用

Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection in Traumatic Head Injury

National Institute of Mental Health and Neuro Sciences, India2 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2021年8月24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
208
试验地点
2
主要终点
Detection rate of intracranial hematoma

研究概览

简要总结

Traumatic brain injury is a common neurosurgical emergency managed in all tertiary and secondary hospitals. Detecting the underlying pathology is a major challenge especially for surgical cases. The outcome differs if the early intervention is performed. Near-infrared spectroscopy (NIRS) based device will detect the hematoma at the bedside. It is not the replacement of a CT scan but can help in triage. This is a large-scale prospective study to establish the role of NIRS device in detecting intracerebral hematoma and correlate the finding with CT scan finding.

详细描述

The light used in the near-infrared spectrum, especially between 700 and 1000 nm, is able to penetrate the human tissue 'optical window'. Once the light has penetrated into the tissue, it is either scattered or absorbed. Light is mostly scattered by bones, skin and cerebral white matter. However, red blood cells, which represent roughly have a low scattering effect and high absorption. Utilising this principle, the emitter and detector could be used to measure the light scattered by the tissues. The 'optical density' of the tissue is calculated and by comparing the left and right hemispheres in the eight contralateral locations of the brain lobes where lesions with extravascular accumulation of haemoglobin can be detected. A NIRS device named Cerebo® was developed by Bioscan Research, Ahmedabad, India. It is a low power non risky device that can screen the patient's head multiple times without causing any side effect. The built in safety features in Cerebo® make it fail safe system for intentional as well as accidental exposure to laser beam. The average power and total power dissipation is very low. The system poses no risk to the patients who will be included in the study.

So far the overall results of detection rate of hematoma using NIRS device are contradictory. It is not the replacement of a CT scan but can help in triage. In the present research the investigators plan to do a large scale prospective study to establish the role of NIRS device in detecting intracerebral hematoma and correlate the finding with CT scan findings.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute traumatic brain injury patients reaching the hospital

排除标准

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

结局指标

主要结局

Detection rate of intracranial hematoma

时间窗: Immediately after the test

To evaluate detection rate of intracranial hematoma using NIRS device Cerebo®, (Bioscan Research, Ahmedabad, India) in hospital.

次要结局

  • Detection rate of clinically significant intracranial hematoma(Immediately after the test)

研究者

发起方
National Institute of Mental Health and Neuro Sciences, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dhaval Shukla

Prof. of Neurosurgery

National Institute of Mental Health and Neuro Sciences, India

研究点 (2)

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