跳至主要内容
临床试验/CTRI/2024/07/071021
CTRI/2024/07/071021尚未招募4 期

Investigating the Clinical Efficacy of CEREBO for early detection of Traumatic Brain Injury

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2024年7月29日最近更新:

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

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Vedang Mahajan

All India Institute of Medical Sciences, Delhi

研究点 (1)

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