Usability Study of CEREBO® - A Novel Non-invasive Intracranial Bleed Detector

Summative Usability Study of CEREBO® in Traumatic Brain Injury Patients to Determine Ease of Use, Ease of Learning and Satisfaction

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.

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®.

Inclusion Criteria:

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.

1. MBBS with Specialisation
2. MBBS
3. Nursing Staff
4. Others

Subjects -

1. Subjects with suspected traumatic brain injury and GCS > 13
2. Of all ages and gender, have understood the study and gave a written informed consent.

Exclusion Criteria:

Subjects -

1. Subjects with active bleeding or scalp laceration
2. Subjects with large extracranial lesions