Craniocerebral Injuries, Crushing Skull Injury, Head Injuries, Head Injuries, Closed, Head Injuries, Multiple, Head Injury Major, Head Injury, Minor, Head Injury, Open, Head Trauma, Head Trauma,Closed, Head Trauma Injury, Head Trauma, Penetrating, Injuries, Craniocerebral, Injuries, Head, Multiple Head Injury, Trauma, Head
Conditions
Brief summary
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
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.
Interventions
DEVICEInfraScanner 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.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status | Within 30 minutes following CT scan | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Volume and Size of Hematoma) | Within 30 minutes following CT scan | 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. |
| Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Depth of Hematoma) | Within 30 minutes following CT scan | 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. |
| Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) | 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. | 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. |
| Identify Reasons CT Not Performed | 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. | CT Scans that are ordered and not performed will have a medical record review to determine the reasons for the missed CT. |
| Causes of Head Trauma as Identified Through the Medical Record | 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. | RTA = Road Traffic Accident |
Countries
Uganda, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 672 |
| Total | 672 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | CT scan unreadable | 277 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | InfraScanner 2000™ |
|---|---|
| Age, Continuous | 32.98 years STANDARD_DEVIATION 13.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 672 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 672 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Uganda | 672 Participants |
| Sex: Female, Male Female | 79 Participants |
| Sex: Female, Male Male | 593 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 33 / 672 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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).
Time frame: Within 30 minutes following CT scan
Population: 180 participants had a positive CT scan; 207 participants had a negative CT scan. One CT per participant.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status | CT positive | Infrascan positive | 158 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status | CT positive | Infrascan negative | 22 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status | CT negative | Infrascan positive | 126 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status | CT negative | Infrascan negative | 81 Participants |
Secondary
Causes of Head Trauma as Identified Through the Medical Record
RTA = Road Traffic Accident
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Causes of Head Trauma as Identified Through the Medical Record | Accidental Injury | 4 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Causes of Head Trauma as Identified Through the Medical Record | Unknown | 2 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Causes of Head Trauma as Identified Through the Medical Record | RTA - Other | 17 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Causes of Head Trauma as Identified Through the Medical Record | RTA - Boda without helmet | 179 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Causes of Head Trauma as Identified Through the Medical Record | RTA - Boda with helmet | 36 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Causes of Head Trauma as Identified Through the Medical Record | RTA - Pedestrian hit by boda | 24 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Causes of Head Trauma as Identified Through the Medical Record | RTA - Pedestrian hit by car or bus | 14 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Causes of Head Trauma as Identified Through the Medical Record | RTA - Car without seatbelt | 12 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Causes of Head Trauma as Identified Through the Medical Record | RTA - Car unknown seatbelt | 9 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Causes of Head Trauma as Identified Through the Medical Record | RTA - Car with seatbelt | 4 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Causes of Head Trauma as Identified Through the Medical Record | RTA - Boda unknown helmet | 3 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Causes of Head Trauma as Identified Through the Medical Record | Assault | 66 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Causes of Head Trauma as Identified Through the Medical Record | Fall | 11 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Causes of Head Trauma as Identified Through the Medical Record | Other | 6 Participants |
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.
Time frame: 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.
Population: Data not collected on 10 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) | 8 = Upper Good Recovery | 47 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) | 7 = Lower Good Recovery | 252 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) | 6 = Upper Moderate Disability | 41 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) | 5 = Lower Moderate Disability | 9 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) | 4 = Upper Severe Disability | 2 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) | 3 = Lower Severe Disability | 0 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) | 2 = Vegetative State | 0 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Clinical Patient Outcomes as Measured by the Glasgow Outcomes Scale (GOSE) | 1 = Dead | 26 Participants |
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.
Time frame: 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.
Population: All CTs were performed.
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.
Time frame: Within 30 minutes following CT scan
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Depth of Hematoma) | CT positive (adjusted for depth) | InfraScan positive (adjusted for depth) | 148 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Depth of Hematoma) | CT positive (adjusted for depth) | InfraScan negative (adjusted for depth) | 17 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Depth of Hematoma) | CT negative (adjusted for depth) | InfraScan positive (adjusted for depth) | 126 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Depth of Hematoma) | CT negative (adjusted for depth) | InfraScan negative (adjusted for depth) | 81 Participants |
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.
Time frame: Within 30 minutes following CT scan
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Volume and Size of Hematoma) | CT positive (adjusted for volume/size) | InfraScan positive (adjusted for volume/size) | 136 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Volume and Size of Hematoma) | CT positive (adjusted for volume/size) | InfraScan negative (adjusted for volume/size) | 15 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Volume and Size of Hematoma) | CT negative (adjusted for size) | InfraScan positive (adjusted for volume/size) | 126 Participants |
| InfraScanner 2000™ and CT (Computerized Tomography) Scan | Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status (Adjusted for Volume and Size of Hematoma) | CT negative (adjusted for size) | InfraScan negative (adjusted for volume/size) | 81 Participants |