Summative Usability Study of CEREBO® in Traumatic Brain Injury Patients to Determine Ease of Use, Ease of Learning and Satisfaction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- To evaluate the summative usability of CEREBO®
研究概览
简要总结
Traumatic Brain Injury (TBI) is the leading cause of death and disability across the globe. Time from injury to treatment is the most critical factor that determines the patient's recovery. Mild TBI with no apparent symptoms are often left undiagnosed, thus delaying the treatment and hence recovery. CEREBO® is a non-invasive, rapid, near-infrared based, point-of-care device that can detect an intracranial bleed at an early stage.
详细描述
This prospective study determines the usability of CEREBO® to detect the intracranial hematoma. The operators will receive a training session before the study and will be evaluated at the end of the study through a survey questionnaire for ease of use, ease of learning and satisfaction. Each operator will examine at least 10 subjects with CEREBO®.
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
- •Operators -
- •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.
- •MBBS with Specialisation
- •Nursing Staff
- •Subjects with suspected traumatic brain injury and GCS > 13
- •Of all ages and gender, have understood the study and gave a written informed consent.
排除标准
- •Subjects with active bleeding or scalp laceration
- •Subjects with large extracranial lesions
结局指标
主要结局
To evaluate the summative usability of CEREBO®
时间窗: 1 year
Assessment of ease of use, ease of learning and satisfaction through the questionnaires filled by the operators.
次要结局
未报告次要终点