Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas
Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas
The goal of this study is to determine the sensitivity, specificity, and positive and
 negative predictive values of the a portable near-infrared-based device (portable NIR-based
 device), the InfraScanner 2000™, to detect intracranial hematomas (epidural hematomas (EDH)
 and/or subdural hematomas (SDH)) in patients hospitalized at Mbarara Regional Referral
 Hospital (MRRH) who have sustained or who are suspected to have sustained head trauma.
When applicable (conscious patient and/or family or legally authorized representative is
 present) the study will be introduced to the patient and relevant parties prior to the
 research team approaching the patient. While head trauma frequently results in impaired
 cognition and/or consciousness, and due to the urgency of these circumstances patients are
 often not accompanied by kin, whenever appropriate, the purpose of the research and the
 procedure will be explained in detail with all questions answered to the patient's and/or
 representative's satisfaction. Because patients who sustain head trauma injuries typically
 remain within the hospital for multiple days for monitoring and care, each participant may
 undergo multiple Computed Tomography (CT) scans over the course of his or her
 hospitalization, affording the opportunity of one to numerous measurements from each patient
 during his or her hospital stay.

 Upon presentation to the casualty unit at MRRH and following each CT scan, the study team
 will approach the patient to scan the patient's cranium with the InfraScanner 2000™ (Image
 A). If permission is granted, the study team member sequentially measure the optical
 absorption for each of the 8 quadrants of the scalp (frontal, temporal, parietal, and
 occipital bilaterally) (Image B). The device is engineered such that the light emitter and
 receiver are spaced 4 cm apart, allowing the light's intensity to be measured between
 adjacent light guides (Image C). This entire procedure, including greeting and scanning the
 patient should take <10 minutes. Subsequent CT scan(s) the patient receives determines the
 number of potential data collections.

 The patient and/or representative may refuse a scan during any encounter, and as such, the
 scan will not be done. For each patient scanned with the InfraScanner 2000™ they will be
 de-identified with a subject number, with age, sex, gender, skin color, hair color, hair
 thickness, mechanism of injury, Glasgow Coma Scale score, and mean time elapsed between CT
 scan and near-infrared measurement. These data will be stored in de-identified form on the
 Research Electronic Data Capture (REDCap) database and/or Microsoft Excel 2016 on a secured
 network drive within the Department of Neurosurgery at Duke.

 The collection period for each research subject concludes 30-days following his or her
 initial measurement with the InfraScanner 2000™, patient discharge, or patient death.
Inclusion Criteria:

 -  Any patient who presents to MRRH with suspected head trauma, who is able to or who has
 a legally authorized representative who is able consent in English, Swahili, or
 Luganda will be considered for this study.

 Exclusion Criteria:

 -  None