Head Trauma Clinical Trial
Official title:
Assessment of Accuracy, Precision, and Feasibility of a Handheld Near-Infrared Light Device (InfraScanner 2000™) in Detecting Subdural and Epidural Hematomas in Patients Admitted to Duke University Hospital: A Pilot Study
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.
;
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