Three clinical studies demonstrated the safety and effectiveness of the B4C System and for its intended use.
Non-invasive ICP Monitoring for HIV-associated Cryptococcal Meningitis
A critically ill adult subject diagnosed with human immunodeficiency virus-associated cryptococcal meningitis received ICP monitoring with a previous sensor version of the B4C System while undergoing standard treatment over thirty-four (34) days. The subject underwent real-time non- invasive ICP monitoring at four defined time points before and after treatment to collect four ICP waveforms. Waveform morphology of the ICP curves at these time points was visually assessed with other recorded clinical parameters to determine whether the waveforms were indicative of the clinical status of the patient. The pulsatile waveform from ICP monitoring on Day 12 before lumbar puncture revealed P2>P1, amplitude of tidal wave greater than that of percussion wave, reflecting characteristics of relative peak height consistent with the presence of neurological symptoms. P1>P2 after lumbar puncture, demonstrating improvement towards the characteristic P1>P2>P3, where P3 is dicrotic wave, as expected with reduction in ICP post-treatment. Morphology of the waveforms obtained from Day 34 were more closely representing normal brain compliance (P1>P2>P3), which is consistent with reduction in ICP following the series of treatment and discharge that same day. Results of this early study demonstrated that the B4C System is able to continuously monitor ICP changes to acquire signals consistent with the patient’s clinical status.
Analysis of a Non-Invasive ICP Monitoring Method in Patients with Traumatic Brain Injury
Seven adult subjects who were admitted to the neurointensive care unit presenting with severe or moderate traumatic brain injury with secondary neurological deterioration requiring intubation and mechanical ventilation were enrolled in the study. The objective of the study was to verify the similarities between the Codman® Microsensor Basic Kit (iICP) and Braincare (nICP) sensors’ waveforms. This assessment sought to provide evidence for the use of the noninvasive sensor as an alternative to invasive ICP assessments in situations where the waveform can provide supplementary clinical information. In addition, the noninvasive intracranial pressure and arterial blood pressure (ABP) waveforms were compared to verify the possible influence of the extracranial peripheral circulation into the noninvasive intracranial pressure signal, acknowledged as a potential limitation of the B4C System.
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The primary endpoint was the comparison of ICP waveform morphology obtained with the nICP and iICP sensors. A secondary endpoint was the comparison of the nICP and ABP waveforms. Waveforms were compared in a lower dimensional space constructed based on signals in the frequency domain. Similarity between the two devices’ signals was inferred from the Euclidean distance between the non-linear projection in a lower dimensional space of the window power spectral densities (PSD) of the respective signals, in which PSD was calculated using the short- term Fourier transform. Intraindividual statistical comparisons were performed using the non- parametric Mann-Whitney U test for not normally distributed data points with a significance level set at p<0.05. Measurement of similarities are presented in the following table.
Table 3.3-1 - Measure of similarities between i-ICP, nICP and ABP
Subject ID | |||||||
|---|---|---|---|---|---|---|---|
Similarities | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
iCP-niICP | 35.0 | 27.2 | 26.9 | 16.9 | 36.3 | 54.7 | 30.3 |
ABP-niICP | 117.3 | 86.6 | 86.9 | 77.9 | 78.1 | 106.6 | 76.3 |
The difference between the iICP-nICP and nICP-ABP was found to be statistically significant for all seven subjects, p<0.05, using the Mann-Whitney U test. Study results demonstrated that a greater similarity exists between the waveforms generated from the signals of the Codman® Microsensor Basic Kit and B4C System than between the B4C System sensor and arterial blood pressure measurements. Although the study had a limited sample size, the intra-individual similarities of the invasive and noninvasive ICP signals as functions of time suggest comparable effectiveness of ICP monitoring between the Braincare Sensor and the invasive Codman® Microsensor Basic Kit, which is representative of the standard of care. Additionally, no adverse events related to the use of the B4C System were reported, supporting safety of the Braincare sensor for monitoring intracranial pressure.
A Prospective Validation Evaluation of a Novel Non-Invasive Sensor Device for Safe and Simplified Intracranial Pressure (ICP) Monitoring
Braincare conducted a prospective, single-center, observational study to assess the comparison of the acquired ICP waveform signal and parameters between the B4C System and standard of care invasive ICP monitoring methods. The study device consisted of the B4C processing and analytical software used with the wired sensor. Although the wired sensor was used in the study, the results reflect the performance of the B4C System.
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