Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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 and Mbarara Regional Referral Hospital: A Pilot Study

Conditions
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Head Trauma, Craniocerebral Injuries, Crushing Skull Injury, Head Injuries, Head Injuries, Multiple, Head Injuries, Closed, Head Trauma,Closed, Head Trauma Injury, Head Trauma, Penetrating, Head Injury, Minor, Head Injury Major, Head Injury, Open, Injuries, Craniocerebral, Injuries, Head, Multiple Head Injury, Trauma, Head

Intervention / Treatment
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* Device: InfraScanner 2000™


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: InfraScanner 2000™<br>All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ upon arrival to the casualty unit at MRRH following CT. Patients will be scanned using the InfraScanner 2000™ following each subsequent CT as allowed by patient or representative. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis. | Device: InfraScanner 2000™<br>* The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of hematomas | Determine whether the InfraScanner 2000™ detects epidural and/or subdural hematomas with adequate precision relative to CT scans to be used as a diagnostic tool for epidural and/or subdural hematomas. | Within 30 minutes following each CT scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate test characteristics | Test characteristics of the InfraScanner 2000™ in identification of hematomas within its detection limits (volume >3.5 mL and depth <2.5 cm) compared to CT scan results as the gold standard. | 18 months after study is closed to accrual | 
| Estimate patient outcomes | Clinical patient outcomes as measured by the Glasgow Outcomes Scale at discharge and 30 days post-discharge. The Glasgow Outcomes Scale is rated from 1 to 8, 1 being death, and 8 being upper good recovery. | Through study completion, defined as 30 days following discharge | 
| Identify reasons CT not performed | CT Scans that are ordered and not performed will have a medical record review to determine the reasons for the missed CT. | Through study completion, defined as 30 days following discharge | 
| Identify causes of head trauma | Causes of head trauma will be identified through the medical record | Through study completion, defined as 30 days following discharge |