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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InfraScanner 2000™ | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InfraScanner 2000™ | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status | Determine whether the InfraScanner 2000 detects epidural and/or subdural hematomas with adequate precision relative to CT scans. Precision is defined as the number of True Positives (Infrascanner says there is a hematoma and the CT shows a hematoma) and True Negatives (Infrascanner says there is NOT a hematoma and the CT does NOT show a hematoma). | Within 30 minutes following CT scan |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Volume and Size of Hematoma) | Test characteristics of the InfraScanner 2000™ in identification of hematomas within its detection limits (volume >3.5 mL) compared to CT scan results as the gold standard. All CTs were reviewed to determine the size and depth from the skull of any hematomas present on the CT. All CT findings were used for the general analysis results to determine the number of True Positives and True Negatives. For the adjusted analyses (size and depth), only the CTs with hematoma sizes (>3.5 ml in volume) or depths (<2.5 cm from the skull) were used. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Haglund, MD, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States | ||
| Mbarara Regional Referral Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41358727 | Derived | Liow YY, Ukachukwu AK, Iversen ES, Ordonez YT, Gramer R, Shlobin NA, Najjuma JN, Fuller AT, Haglund MM, Kitya D, Kolls BJ. Assessment of a Handheld Near-Infrared Light Device in Detecting Intracranial Hematomas in Mbarara, Uganda. Neurosurgery. 2025 Dec 8. doi: 10.1227/neu.0000000000003873. Online ahead of print. |
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Participants were recruited from Mbarara Regional Referral Hospital in Mbarara, Uganda from the casualty ward. Participants were eligible for participation if they had a traumatic brain injury and could complete a CT and infrascan within 30 minutes of each other.
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| ID | Title | Description |
|---|---|---|
| FG000 | InfraScanner 2000™ | 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. InfraScanner 2000™: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2022 |
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| Within 30 minutes following CT scan |
| Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Depth of Hematoma) | Test characteristics of the InfraScanner 2000™ in identification of hematomas within its detection limits (depth <2.5 cm) compared to CT scan results as the gold standard. All CTs were reviewed to determine the size and depth from the skull of any hematomas present on the CT. All CT findings were used for the general analysis results to determine the number of True Positives and True Negatives. For the adjusted analyses (size and depth), only the CTs with hematoma sizes (>3.5 ml in volume) or depths (<2.5 cm from the skull) were used. | Within 30 minutes following CT scan |
| Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) | Clinical patient outcomes as measured by the Glasgow Outcomes Scale (GOSE) at discharge. The GOSE is rated from 1 to 8, 1 being death and 8 being upper good recovery. | Through study completion, defined as 30 days after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan. |
| 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 after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan. |
| Causes of Head Trauma as Identified Through the Medical Record | RTA = Road Traffic Accident | Through study completion, defined as 30 days after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan. |
| Mbarara |
| Uganda |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | InfraScanner 2000™ | 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. InfraScanner 2000™: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status | Determine whether the InfraScanner 2000 detects epidural and/or subdural hematomas with adequate precision relative to CT scans. Precision is defined as the number of True Positives (Infrascanner says there is a hematoma and the CT shows a hematoma) and True Negatives (Infrascanner says there is NOT a hematoma and the CT does NOT show a hematoma). | 180 participants had a positive CT scan; 207 participants had a negative CT scan. One CT per participant. | Posted | Count of Participants | Participants | Within 30 minutes following CT scan |
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| Secondary | Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Volume and Size of Hematoma) | Test characteristics of the InfraScanner 2000™ in identification of hematomas within its detection limits (volume >3.5 mL) compared to CT scan results as the gold standard. All CTs were reviewed to determine the size and depth from the skull of any hematomas present on the CT. All CT findings were used for the general analysis results to determine the number of True Positives and True Negatives. For the adjusted analyses (size and depth), only the CTs with hematoma sizes (>3.5 ml in volume) or depths (<2.5 cm from the skull) were used. | Participants with hematomas within the InfraScanner's detection limits (as determined by CT scan). 151 participants had a positive CT scan and 207 participants had a negative CT scan when adjusted for hematoma volume/size. One CT per participant. | Posted | Count of Participants | Participants | Within 30 minutes following CT scan |
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| Secondary | Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Depth of Hematoma) | Test characteristics of the InfraScanner 2000™ in identification of hematomas within its detection limits (depth <2.5 cm) compared to CT scan results as the gold standard. All CTs were reviewed to determine the size and depth from the skull of any hematomas present on the CT. All CT findings were used for the general analysis results to determine the number of True Positives and True Negatives. For the adjusted analyses (size and depth), only the CTs with hematoma sizes (>3.5 ml in volume) or depths (<2.5 cm from the skull) were used. | Participants with hematomas within the InfraScanner's detection limits (as determined by CT scan). 165 participants had a positive CT scan and 207 participants had a negative CT scan when adjusted for hematoma depth. One CT per participant. | Posted | Count of Participants | Participants | Within 30 minutes following CT scan |
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| Secondary | Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) | Clinical patient outcomes as measured by the Glasgow Outcomes Scale (GOSE) at discharge. The GOSE is rated from 1 to 8, 1 being death and 8 being upper good recovery. | Data not collected on 10 participants. | Posted | Count of Participants | Participants | Through study completion, defined as 30 days after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan. |
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| Secondary | 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. | All CTs were performed. | Posted | Through study completion, defined as 30 days after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan. |
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| Secondary | Causes of Head Trauma as Identified Through the Medical Record | RTA = Road Traffic Accident | Posted | Count of Participants | Participants | Through study completion, defined as 30 days after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan. |
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Through study completion, defined as 30 days after CT scan or at discharge from hospital, death, or prior to leaving hospital against medical advice, whichever occurred first. All participants were assessed at a maximum of 30 days after CT scan.
All-cause mortality instances were due to the participants' TBIs (traumatic brain injuries). Serious Adverse Events and/or Other (Not Including Serious) Adverse Events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | InfraScanner 2000™ and CT (Computerized Tomography) Scan | 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. InfraScanner 2000™: 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. | 33 | 672 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony 'Tony' T. Fuller, MD, MScGH | Duke University | 919-613-1813 | anthony.fuller@duke.edu |
| Jun 6, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D016489 | Head Injuries, Closed |
| D020197 | Head Injuries, Penetrating |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D014950 | Wounds, Penetrating |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| CT negative |
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