Infrascanner
DeviceThe main Near-Infrared spectroscopy (NIRS) head measurement
NCT Number: NCT00576147
The purposes of this study are:
1. To determine the sensitivity and specificity of the Near-Infrared Spectroscopy (NIRS) measurements for identifying intracranial hematomas due to trauma. 2. To determine the reproducibility of the Near-Infrared Spectroscopy (NIRS) measurements with different operators and at different centers
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Interventional
Not applicable
Johns Hopkins University, Baltimore, Maryland, United States
The principle used in identifying intracranial hematomas with Near-infrared spectroscopy (NIRS) is that extravascular blood absorbs Near-infrared light more than intravascular blood since there is a greater (usually 10-fold greater) concentration of hemoglobin in the acute hematoma then in the brain tissue where blood is contained within vessels. Therefore, the absorbance of Near-infrared light is greater (and therefore the reflected light less) on the side of the brain containing a hematoma, than on the uninjured side.
The NIRS sensor is placed successively in the left and right frontal, temporal, parietal, and occipital areas of the head and the absorbance of light at selected wavelengths is recorded. The difference in optical density in the different areas is calculated.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The main Near-Infrared spectroscopy (NIRS) head measurement
Time frame: 2 years
We will report Sensitivity and Specificity of NIRS device as compared to CT scanner to detect hematomas of more than 3.5 mL in volume and less than 2.5 cm from the surface of the brain.
Sensitivity is the ratio between true positives to all positive measurements. Specificity is the ratio between true negatives to all negative measurements.
InfraScan, Inc.
Industry
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