Comprehensive Assessment of CEREBO to evaluate its clinical performance, utility and Usability in the Brain Injury Management
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Sensitivity, Specificity, Accuracy and other clinical parameters of CEREBO in detecting intracranial injury in TBI
研究概览
简要总结
This study will evaluate two key aspects of CEREBO. Firstly, the study will rigorously evaluate the clinical performance of CEREBO in accurately detecting the intracranial injuries, by comparing its diagnostic outcomes with those obtained from standard imaging techniques such as CT scans. Secondly, it will assess CEREBO’s impact on operational efficiency by measuring its ability to reduce the number of referrals from peripheral hospitals to the study site by identifying patients with no intracranial injury but were referred for head CT/MRI scans. Through these dual objectives, the trial aims to provide comprehensive insights into both the operational and clinical benefits of implementing CEREBO in the management of brain injuries, with the ultimate goal of improving patient outcomes and streamlining emergency care protocols.
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
- •All patients with a suspected head injury and referred for head CT/MRI scan.
排除标准
- •Patients with scalp bruises or hematoma.
结局指标
主要结局
Sensitivity, Specificity, Accuracy and other clinical parameters of CEREBO in detecting intracranial injury in TBI
时间窗: 3 years
次要结局
- To evaluate the number of referrals of TBI patients from peripheral hospitals that could have been prevented(3 years)
- To assess the usability of CEREBO® among healthcare professionals through survey questionnaires.(3 years)
研究者
Dr Zahir Quazi
Datta Meghe Institute of Higher Education & Research
