Summative Usability Study of a Novel Device - CEREBO® for Non Invasive Detection of Intracranial Haemorrhage
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- To assess the usability of CEREBO® to detect intracranial haemorrhage
研究概览
简要总结
Traumatic brain injury is one of the most common reasons for visits to the Emergency Department. More than 90% of patients who have suffered from head trauma present with a mild traumatic brain injury. Most of these patients do not present any symptom at the time of diagnosis thus delaying the detection. CEREBO®, a non-invasive, portable, rapid, point-of-care intracranial haemorrhage detector can avoid delayed detection by decreasing the time from injury to the initial CT scan. The study aims at assessing the summative usability of the device by determining its ease of use, ease of learning and satisfaction among the medical health professionals. The participants will be trained before the study and will be assessed periodically. Each participant will use the device on at least 10 subjects.
详细描述
A prospective interventional study designed to assess the summative usability and rapidity of CEREBO® - a portable device to detect intracranial haemorrhage. 10 participants from a Primary Health Centre will be enrolled in this study. The participants will be trained by the study staff before the study. The participant will fill in a questionnaire periodically. At the end of the study, the statistical analysis will be performed on the recorded data to establish the ease of use, ease of learning and satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medical health professionals >18 years of age with a valid medical license to practice medicine belonging to one of the following categories and have given a written consent to participate in the study.
- •Of all ages and gender, have understood the study and gave a written informed consent.
排除标准
- •Cognitively impaired subjects unable to understand the study procedure
结局指标
主要结局
To assess the usability of CEREBO® to detect intracranial haemorrhage
时间窗: 2 week
A questionnaire filled by the participants will be assessed by the study team to assess the ease of use, ease of learning and satisfaction
次要结局
- To assess the rapidity of CEREBO® to detect intracranial haemorrhage(2 week)