Investigating the Clinical Efficacy of CEREBO for early detection of Traumatic Brain Injury
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- To evaluate the triaging efficacy of CEREBO® by calculating the
研究概览
简要总结
The primary purpose of this study is to rigorously evaluate the clinical efficacy of CEREBO, a non-invasive intracranial injury detection device, in identifying traumatic brain injuries (TBI). This encompasses assessing the device’s accuracy in determining the presence or absence of intracranial injuries in TBI patients. Additionally, the study aims to quantify the potential impact of CEREBO on operational efficiencies within clinical settings, specifically by measuring and comparing the experimental group (using CEREBO) and the control group (standard care) to establish CEREBO®’s efficacy in patient triage by quantifying the incidence of over-triage and under-triage. This will help determine if the introduction of CEREBO can significantly reduce the time taken for TBI patients to receive crucial diagnostic imaging. Lastly, the study seeks to thoroughly evaluate the usability of the CEREBO device, focusing on aspects such as the ease of use, time efficiency of scans, and the learning curve associated with its operation, to ensure its practical applicability in diverse healthcare environments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 0.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Traumatic brain injury patients arriving at the emergency department and referred for a head CT scan.
排除标准
- •History of neurosurgical procedure (e.g. decompressive craniectomy) with residual bone flap.
结局指标
主要结局
To evaluate the triaging efficacy of CEREBO® by calculating the
时间窗: 3 years
1. Sensitivity
时间窗: 3 years
2. Specificity
时间窗: 3 years
3. Accuracy
时间窗: 3 years
4. Positive Predictive Value
时间窗: 3 years
5. Negative Predictive Value
时间窗: 3 years
次要结局
- To evaluate the utility of CEREBO® in reducing the mean transfer time from triage to treatment(3 years)
- To assess the usability of CEREBO® among healthcare professionals through survey questionnaires(3 years)
研究者
Dr Vedang Mahajan
All India Institute of Medical Sciences, Delhi
