跳至主要内容
临床试验/CTRI/2024/07/070978
CTRI/2024/07/070978尚未招募不适用

Comprehensive Assessment of CEREBO to evaluate its clinical performance, utility and Usability in the Brain Injury Management

Indian Council of Medical Research (ICMR)1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2024年7月29日最近更新:

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

发起方
Indian Council of Medical Research (ICMR)
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Zahir Quazi

Datta Meghe Institute of Higher Education & Research

研究点 (1)

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