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Table 3.3-1 - Measure of similarities between iICP, 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.
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