Assessment of Accuracy, Precision, and Feasibility of CEREBO® - a NearInfrared Light Device to detect and categorize the intracranial hematoma in patientswith suspected brain injury compared to head CT scan as the gold standard:Aprospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Sensitivity of CEREBO®
研究概览
简要总结
Traumatic Brain Injury (TBI) is the leading cause of death and disability across the globe. Time from injury to treatment is the most critical factor that determines the patient’s recovery. Mild TBI with no apparent symptoms are often left undiagnosed, thus delaying the treatment and hence recovery. This observational prospective study determines the efficacy of CEREBO® to detect the intracranial hematoma in comparison with the head CT scan. CEREBO®is a non-invasive, rapid, near-infrared based, point-of-care device. The study also aims to categorise the hematoma based on the bleed volume and depth. Early intracranial hemorrhage detection can help in the patient triaging thus increasing the chances of survival.
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
- •Patients with a head injury referred for a CT scan within 72 hours from the onset of first symptoms of closed head injury.
排除标准
- •Patients with scalp bruises or scalp hematoma
- •History of neurosurgical procedure (e.g. decompressive craniectomy) with residual bone flap.
结局指标
主要结局
Sensitivity of CEREBO®
时间窗: 1 year
Specificity of CEREBO®
时间窗: 1 year
Accuracy of CEREBO®
时间窗: 1 year
Positive and Negative Predictive Value of CEREBO®
时间窗: 1 year
次要结局
- Categorisation of intracranial hematoma based on the bleed volume and depth of hematoma using CEREBO®(Perform the usability study)
