Abstract
IntroductionWe sought to validate a handheld, near-infrared spectroscopy (NIRS) device for detecting intracranial hematomas in children with head injury.MethodsEligible patients were those <18 years old who were admitted to the emergency department at three academic children’s hospitals with head trauma and who received a clinically indicated head computed tomography (HCT). Measurements were obtained by a blinded operator in bilateral frontal, temporal, parietal, and occipital regions. Qualifying hematomas were a priori determined to be within the brain scanner’s detection limits of >3.5 milliliters in volume and <2.5 centimeters from the surface of the brain. The device’s measurements were positive if the difference in optical density between hemispheres was >0.2 on three successive scans. We calculated diagnostic performance measures with corresponding exact two-sided 95% Clopper-Pearson confidence intervals (CI). Hypothesis test evaluated whether predictive performance exceeded chance agreement (predictive Youden’s index > 0).ResultsA total of 464 patients were enrolled and 344 met inclusion for primary data analysis: 10.5% (36/344) had evidence of a hematoma on HCT, and 4.7% (16/344) had qualifying hematomas. The handheld brain scanner demonstrated a sensitivity of 58.3% (21/36) and specificity of 67.9% (209/308) for hematomas of any size. For qualifying hematomas the scanner was designed to detect, sensitivity was 81% (13/16) and specificity was 67.4% (221/328). Predictive performance exceeded chance agreement with a predictive Youden’s index of 0.11 (95% CI, 0.10 – 0.15; P < 0.001) for all hematomas, and 0.09 (95% CI, 0.08 – 0.12; P < 0.001) for qualifying hematomas.ConclusionThe handheld brain scanner can non-invasively detect a subset of intracranial hematomas in children and may serve an adjunctive role to head-injury neuroimaging decision rules that predict the risk of clinically significant intracranial pathology after head trauma.
Highlights
We sought to validate a handheld, near-infrared spectroscopy (NIRS) device for detecting intracranial hematomas in children with head injury
While there are multiple decision rules that predict the risk of a significant intracranial injury in children with head trauma, a substantial proportion of children classified as “not low” risk may require an extended period of observation or neuroimaging to exclude the presence of an intracranial hematoma that may require neurosurgical intervention.[2]
We evaluated whether device performance was associated with the time interval between the head computed tomography (HCT) and the handheld device assessment since prior Infrascanner studies used a maximal interval between the HCT and device assessment of 40 minutes,[8] and this study initially had a limit of 40 minutes prior to 2016 when we lengthened the maximum to six hours to address enrollment issues
Summary
We sought to validate a handheld, near-infrared spectroscopy (NIRS) device for detecting intracranial hematomas in children with head injury. 760,000 children and adolescents less than 18 years old with head trauma undergo evaluation in United States (US) emergency departments (ED) annually.[1] While there are multiple decision rules that predict the risk of a significant intracranial injury in children with head trauma, a substantial proportion of children classified as “not low” risk may require an extended period of observation or neuroimaging to exclude the presence of an intracranial hematoma that may require neurosurgical intervention.[2] An expanding hematoma can lead to significant neurological morbidity or death due to brainstem compression or further ischemic injury. A computed tomography scan of the head (HCT) is the clinical standard for emergent identification and localization of acute intracranial hematomas. The ionizing radiation increases the risk of developing malignancies.[3] Notably, 26% of children evaluated for mild head injury will undergo a HCT, exposing a large population of children each year to ionizing radiation.[4]
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