Clinical Evaluation of a Microwave-Based Device for Detection of Traumatic Intracranial Hemorrhage

Johan Ljungqvist, Stefan Candefjord, Mikael Persson, Lars Jönsson, Thomas Skoglund, Mikael Elam, Johan Ljungqvist, Stefan Candefjord, Mikael Persson, Lars Jönsson, Thomas Skoglund, Mikael Elam

Abstract

Traumatic brain injury (TBI) is the leading cause of death and disability among young persons. A key to improve outcome for patients with TBI is to reduce the time from injury to definitive care by achieving high triage accuracy. Microwave technology (MWT) allows for a portable device to be used in the pre-hospital setting for detection of intracranial hematomas at the scene of injury, thereby enhancing early triage and allowing for more adequate early care. MWT has previously been evaluated for medical applications including the ability to differentiate between hemorrhagic and ischemic stroke. The purpose of this study was to test whether MWT in conjunction with a diagnostic mathematical algorithm could be used as a medical screening tool to differentiate patients with traumatic intracranial hematomas, chronic subdural hematomas (cSDH), from a healthy control (HC) group. Twenty patients with cSDH and 20 HC were measured with a MWT device. The accuracy of the diagnostic algorithm was assessed using a leave-one-out analysis. At 100% sensitivity, the specificity was 75%-i.e., all hematomas were detected at the cost of 25% false positives (patients who would be overtriaged). Considering the need for methods to identify patients with intracranial hematomas in the pre-hospital setting, MWT shows promise as a tool to improve triage accuracy. Further studies are under way to evaluate MWT in patients with other intracranial hemorrhages.

Keywords: chronic subdural hematoma; intracranial hemorrhage detection; microwave technology; traumatic brain injury; triage.

Conflict of interest statement

M.P. is founder and main owner of Medfield Diagnostics AB. M.E. serves as unpaid consultant to Medfield Diagnostics AB. For the remaining authors, no other competing financial interests exist.

Figures

FIG. 1.
FIG. 1.
The Strokefinder MD100 device (Medfield Diagnostics AB, Gothenburg, Sweden). Reprinted with permission.
FIG. 2.
FIG. 2.
The reflection and transmission coefficients for antennas 1 and 2 (at subject's forehead) and antennas 7 and 8 (at back of subject's head) were removed, except for channels between the lateral antennas (3 to 6) and forehead/back of head antennas. The dashed lines indicate the channels that were removed.
FIG. 3.
FIG. 3.
A typical appearance of a cSDH on the left side (patient P3) on a computed tomography scan, with its characteristic crescent-shaped form spanning over the coronal and lambdoid sutural margins. The hematoma is in the hypodense phase. Notice also the significant midline shift.
FIG. 4.
FIG. 4.
The receiver operating characteristic curve and area under the curve (AUC) value for the leave-one-out cross-validation procedure.
FIG. 5.
FIG. 5.
Scatter plot of the classifier decision value for all subjects. The patients have been plotted in increasing order of total hematoma size (for patients with bilateral hematoma, the left and right side volumes were summarized) from left to right. The controls are plotted in chronological order from left to right. The dashed line shows the decision value for the classifier yielding 100% sensitivity at 75% specificity. The receiver operating characteristic curve (Fig. 4) was constructed by adjusting the decision value—i.e., moving the dashed line and calculating the sensitivity and specificity for all possible decision values.

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