Clinical Performance of the Brain4care System for Noninvasive Detection of Intracranial Hypertension.

Background: Noninvasive methods for detecting intracranial hypertension (IH) are of growing importance in clinical settings. This study evaluates the clinical performance of the brain4care (B4C) System, which captures pulsatile cranial expansions that reveal a surrogate intracranial pressure (ICP) waveform and subsequently derives the P2/P1 ratio and time-to-peak (TTP) parameters to predict IH.

Methods: This was a retrospective study conducted across multiple centers that included a total of 124 patients. Invasively monitored ICP and noninvasive B4C waveforms were recorded simultaneously from patients with acute brain injuries. Data were analyzed using specific cutoff values for the estimated P2/P1 ratio (ranging from 0.8 to 1.4) and TTP (at 0.3) to assess their diagnostic accuracy. Sensitivity and specificity for detecting IH (ICP > 20 mm Hg) were determined based on these metrics.

Results: The estimated P2/P1 ratio demonstrated a sensitivity of 92% and specificity of 19% at a threshold of 0.8, indicating high sensitivity for ruling out IH. At a ratio of 1.4, the specificity improved to 90%, suggesting its effectiveness for assessing IH. For TTP, a threshold of 0.3 was identified as the optimal cutoff, offering a specificity of 92%.

Conclusions: The B4C System provides a viable, noninvasive approach to assessing IH. The study underscores the clinical utility of the P2/P1 ratio and TTP in detecting and ruling out IH, offering a significant alternative to invasive ICP monitoring methods.