The VITAL study and overall pooled analysis with the VIPS non-invasive stroke detection device

INTRODUCTION: Effective triage of patients with emergent large vessel occlusion (ELVO) to endovascular therapy capable centers may decrease time to treatment and improve outcome for these patients. Here we performed a derivation study to evaluate the accuracy of a portable, non-invasive, and easy to use severe stroke detector. METHODS: The volumetric impedance phase shift spectroscopy (VIPS) device was used to assign a bioimpedance asymmetry score to 248 subjects across three cohorts, including 41 subjects presenting as acute stroke codes at a major comprehensive stroke center (CSC), 79 healthy volunteers, and 128 patients presenting to CSCs with a wide variety of brain pathology including additional stroke codes. Diagnostic parameters were calculated for the ability of the device to discern (1) severe stroke from minor stroke and (2) severe stroke from all other subjects. Patients with intracranial hardware were excluded from the analysis. RESULTS: The VIPS device was able to differentiate severe stroke from minor strokes with a sensitivity of 93% (95% CI 83 to 98), specificity of 92% (95% CI 75 to 99), and an area under the curve (AUC) of 0.93 (95% CI 0.85 to 0.97). The device was able to differentiate severe stroke from all other subjects with a sensitivity of 93% (95% CI 83 to 98), specificity of 87% (95% CI 81 to 92), and an AUC of 0.95 (95% CI 0.89 to 0.96). CONCLUSION: The VIPS device is a portable, non-invasive, and easy to use tool that may aid in the detection of severe stroke, including ELVO, with a sensitivity of 93% and specificity of 92% in this derivation study. This device has the potential to improve the triage of patients suffering severe stroke.