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 Duke University Hospital (DUH)
 who have sustained or who are suspected to have sustained head trauma and have consequently
 received a brain computed tomography (CT) scan(s).
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 CT scans over the course of his or her hospitalization, affording the
 opportunity to one to numerous measurements from each patient during his or her hospital
 stay.

 Within 30 minutes following each CT scan, the study team will approach the patient to scan
 the patient's cranium with the InfraScanner 2000™ (Image A). The procedure will entail
 placing 8 plastic light guides upon the patient's scalp. The study team member will use the
 device to sequentially emit light through each of the 8 light guides so that the light is
 incident upon scalp (Image B). The device is engineered such that the light emitter and
 receiver are spaced ~4cm apart, allowing the light's intensity to be measured between
 adjacent light guides (Image C). This entire procedure, including greeting the patient,
 placing the light guides, gathering the data, and removing the light guides should take ~10
 minutes each time. The number of CT scans the patient receives determines the number of
 potential data collections. The patient will be approached by the study team following each
 CT scan to be scanned with the InfraScanner 2000™ (20). 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 Research Electronic Data Capture (REDCap) and/or
 Microsoft Excel 2016 on a secured DHTS server (S:\NSU_IRB\Pro00087011).

 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 Duke University Hospital with suspected head trauma and
 receives a brain CT scan will be considered for this study.

 Exclusion Criteria:

 -  None