Prospective Evaluation of Noninvasive HeadSense Intracranial Pressure Monitor in Traumatic Brain Injury Patients Undergoing Invasive Intracranial Pressure Monitoring.

Background: Currently, intracranial pressure (ICP) is measured by invasive methods with a significant risk of infectious and hemorrhagic complications. Because of these high risks, there is a need for a noninvasive ICP (nICP) monitor with an accuracy similar to that of an invasive ICP (iICP) monitor.
Objective: We sought to assess prospectively the accuracy and precision of an nICP monitor compared with iICP measurement in severe traumatic brain injury (TBI) patients.
Methods: Participants were ICP-monitored patients who had sustained TBI. In parallel with the standard invasive ICP measurements, nICP was measured by the HeadSense HS-1000, which is based on sound propagation. The device generated an acoustic signal using a small transmitter, placed in the patient's ear, and picked up by an acoustic sensor placed in the other ear. The signal is then analyzed using proprietary algorithms, and the ICP value is calculated in millimeter of mercury (mm Hg).
Results: Analysis of 2911 paired iICP and nICP measurements from 14 severe TBI patients showed a good accuracy of the nICP monitor indicated by a mean difference of 0.5 mm Hg. The precision was also good with a standard deviation of 3.9 mm Hg. The Pearson r correlation was 0.604 (P < 0.001).
Conclusions: The HeadSense HS-1000 nICP monitor seems sufficiently accurate to measure the ICP in severe TBI patients, is patient friendly, and has minimal risk of complications.
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