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 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).
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 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.
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 Duke University Hospital with suspected head trauma and receives a brain CT scan will be considered for this study.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level | Up to 30 days after first CT scan | Percentage of subjects with hematomas detected by CT who had hematoma detected by Infrascanner 2000 TM. |
| Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Scan Level | Up to 30 days after first CT scan | Percentage of CT scans with hematomas detected that had hematoma detected by Infrascanner 2000 TM. |
| Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level | Up to 30 days after first CT scan | Percentage of patients with no hematomas detected by CT who had no hematoma detected by Infrascanner 2000 TM. |
| Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level | Up to 30 days after first CT scan | Percentage of CT scans with no hematomas detected that had no hematoma detected by Infrascanner 2000 TM. |
| False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level | Up to 30 days after first CT scan | Percentage of patients with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM. |
| False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level | Up to 30 days after first CT scan | Percentage of scans with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM. |
| False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level | Up to 30 days after first CT scan | Percentage of patients with hematomas detected by CT that had no hematoma detected by Infrascanner 2000 TM. |
| False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level | Up to 30 days after first CT scan | Percentage of scans with hematomas detected by CT that had no hematoma detected by Infrascanner 2000 TM. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level | Up to 30 days after first CT scan | Percentage of CT scans with hematomas within detection limits detected by CT that were detected by Infrascanner 2000 TM. |
| Sensitivity in Identification of Hematomas Within Detection Limits, at the Patient Level | Up to 30 days after first CT scan | Percentage of subjects with hematomas within detection limits detected by CT who had hematoma detected by Infrascanner 2000 TM. |
| Specificity in Identification of Hematomas Within Detection Limits, at the Patient Level | Up to 30 days after first CT scan | Percentage of patients with no hematomas within detection limits detected by CT who had no hematoma detected by Infrascanner 2000 TM. |
| Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level | Up to 30 days after first CT scan | Percentage of subjects with hematomas within detection limits detected by CT that were detected by Infrascanner 2000 TM. |
| False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level | Up to 30 days after first CT scan | Percentage of subjects with hematomas within detection limits detected by CT where no hematoma was detected by Infrascanner 2000 TM. |
| False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level | Up to 30 days after first CT scan | Percentage of CT scans with hematomas within detection limits detected by CT where no hematoma was detected by Infrascanner 2000 TM. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| InfraScanner 2000™ All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. 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. | 500 |
| Total | 500 |
Baseline characteristics
| Characteristic | InfraScanner 2000™ |
|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 25.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 104 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 396 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 28 Participants |
| Race (NIH/OMB) Black or African American | 168 Participants |
| Race (NIH/OMB) More than one race | 63 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 10 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 231 Participants |
| Region of Enrollment United States | 500 participants |
| Sex: Female, Male Female | 211 Participants |
| Sex: Female, Male Male | 289 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 500 |
| other Total, other adverse events | 0 / 500 |
| serious Total, serious adverse events | 0 / 500 |
Outcome results
Primary
False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level
Percentage of patients with hematomas detected by CT that had no hematoma detected by Infrascanner 2000 TM.
Time frame: Up to 30 days after first CT scan
Population: For participants who had more than one scan, the first scan was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InfraScanner 2000™ | False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level | 3.8 percentage |
Primary
False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level
Percentage of scans with hematomas detected by CT that had no hematoma detected by Infrascanner 2000 TM.
Time frame: Up to 30 days after first CT scan
Population: Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InfraScanner 2000™ | False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level | 5.2 percentage |
Primary
False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level
Percentage of patients with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM.
Time frame: Up to 30 days after first CT scan
Population: For participants who had more than one scan, the first scan was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InfraScanner 2000™ | False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level | 16.0 percentage |
Primary
False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level
Percentage of scans with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM.
Time frame: Up to 30 days after first CT scan
Population: Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InfraScanner 2000™ | False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level | 10.1 percentage |
Primary
Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level
Percentage of subjects with hematomas detected by CT who had hematoma detected by Infrascanner 2000 TM.
Time frame: Up to 30 days after first CT scan
Population: For participants who had more than one scan, the first scan was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InfraScanner 2000™ | Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level | 85.6 percentage |
Primary
Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Scan Level
Percentage of CT scans with hematomas detected that had hematoma detected by Infrascanner 2000 TM.
Time frame: Up to 30 days after first CT scan
Population: Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InfraScanner 2000™ | Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Scan Level | 88.5 percentage |
Primary
Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level
Percentage of patients with no hematomas detected by CT who had no hematoma detected by Infrascanner 2000 TM.
Time frame: Up to 30 days after first CT scan
Population: For participants who had more than one scan, the first scan was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InfraScanner 2000™ | Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level | 95.7 percentage |
Primary
Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level
Percentage of CT scans with no hematomas detected that had no hematoma detected by Infrascanner 2000 TM.
Time frame: Up to 30 days after first CT scan
Population: Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InfraScanner 2000™ | Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level | 95.5 percentage |
Secondary
False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level
Percentage of subjects with hematomas within detection limits detected by CT where no hematoma was detected by Infrascanner 2000 TM.
Time frame: Up to 30 days after first CT scan
Population: Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| InfraScanner 2000™ | False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level | epidural hematoma (EDH) | 0.0 percentage |
| InfraScanner 2000™ | False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level | subdural hematoma (SDH) | 0.5 percentage |
| InfraScanner 2000™ | False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level | subarachnoid (SAH) | 0.8 percentage |
| InfraScanner 2000™ | False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level | intracerebral (IH) | 0.0 percentage |
Secondary
False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level
Percentage of CT scans with hematomas within detection limits detected by CT where no hematoma was detected by Infrascanner 2000 TM.
Time frame: Up to 30 days after first CT scan
Population: Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| InfraScanner 2000™ | False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level | epidural hematoma (EDH) | 0.3 percentage |
| InfraScanner 2000™ | False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level | subdural hematoma (SDH) | 0.5 percentage |
| InfraScanner 2000™ | False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level | subarachnoid (SAH) | 0.8 percentage |
| InfraScanner 2000™ | False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level | intracerebral (IH) | 0.3 percentage |
Secondary
Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level
Percentage of subjects with hematomas within detection limits detected by CT that were detected by Infrascanner 2000 TM.
Time frame: Up to 30 days after first CT scan
Population: Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| InfraScanner 2000™ | Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level | subarachnoid (SAH) | 75.0 percentage |
| InfraScanner 2000™ | Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level | epidural hematoma (EDH) | 100.0 percentage |
| InfraScanner 2000™ | Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level | subdural hematoma (SDH) | 96.9 percentage |
| InfraScanner 2000™ | Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level | intracerebral (IH) | 100.0 percentage |
Secondary
Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level
Percentage of CT scans with hematomas within detection limits detected by CT that were detected by Infrascanner 2000 TM.
Time frame: Up to 30 days after first CT scan
Population: Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| InfraScanner 2000™ | Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level | epidural hematoma (EDH) | 90.9 percentage |
| InfraScanner 2000™ | Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level | subdural hematoma (SDH) | 98.3 percentage |
| InfraScanner 2000™ | Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level | subarachnoid (SAH) | 88.0 percentage |
| InfraScanner 2000™ | Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level | intracerebral (IH) | 96.2 percentage |
Secondary
Sensitivity in Identification of Hematomas Within Detection Limits, at the Patient Level
Percentage of subjects with hematomas within detection limits detected by CT who had hematoma detected by Infrascanner 2000 TM.
Time frame: Up to 30 days after first CT scan
Population: For participants who had more than one scan, the first scan was used. Analysis was completed in a subset of participants who had hematomas within detection limits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InfraScanner 2000™ | Sensitivity in Identification of Hematomas Within Detection Limits, at the Patient Level | 94.2 percentage |
Secondary
Specificity in Identification of Hematomas Within Detection Limits, at the Patient Level
Percentage of patients with no hematomas within detection limits detected by CT who had no hematoma detected by Infrascanner 2000 TM.
Time frame: Up to 30 days after first CT scan
Population: For participants who had more than one scan, the first scan was used. Analysis was completed in a subset of participants who had hematomas within detection limits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InfraScanner 2000™ | Specificity in Identification of Hematomas Within Detection Limits, at the Patient Level | 95.7 percentage |