The finger-cuff system CNAP (CNSystems Medizintechnik, Graz, Austria) allows non-invasive automated measurement of pulse pressure variation (PPVCNAP). We sought to validate the PPVCNAP-algorithm and investigate the agreement between PPVCNAP and arterial catheter-derived manually calculated pulse pressure variation (PPVINV). This was a prospective method comparison study in patients having neurosurgery. PPVINV was the reference method. We applied the PPVCNAP-algorithm to arterial catheter-derived blood pressure waveforms (PPVINV−CNAP) and to CNAP finger-cuff-derived blood pressure waveforms (PPVCNAP). To validate the PPVCNAP-algorithm, we compared PPVINV−CNAP to PPVINV. To investigate the clinical performance of PPVCNAP, we compared PPVCNAP to PPVINV. We used Bland–Altman analysis (absolute agreement), Deming regression, concordance, and Cohen's kappa (predictive agreement for three pulse pressure variation categories). We analyzed 360 measurements from 36 patients. The mean of the differences between PPVINV−CNAP and PPVINV was −0.1% (95% limits of agreement (95%-LoA) −2.5 to 2.3%). Deming regression showed a slope of 0.99 (95% confidence interval (95%-CI) 0.91 to 1.06) and intercept of −0.02 (95%-CI −0.52 to 0.47). The predictive agreement between PPVINV−CNAP and PPVINV was 92% and Cohen’s kappa was 0.79. The mean of the differences between PPVCNAP and PPVINV was −1.0% (95%-LoA−6.3 to 4.3%). Deming regression showed a slope of 0.85 (95%-CI 0.78 to 0.91) and intercept of 0.10 (95%-CI −0.34 to 0.55). The predictive agreement between PPVCNAP and PPVINV was 82% and Cohen’s kappa was 0.48. The PPVCNAP-algorithm reliably calculates pulse pressure variation compared to manual offline pulse pressure variation calculation when applied on the same arterial blood pressure waveform. The absolute and predictive agreement between PPVCNAP and PPVINV are moderate.
BACKGROUND The effect of different methods for data sampling and data processing on the results of comparative statistical analyses in method comparison studies of continuous arterial blood pressure (AP) monitoring systems remains unknown. OBJECTIVE We sought to investigate the effect of different methods for data sampling and data processing on the results of statistical analyses in method comparison studies of continuous AP monitoring systems. DESIGN Prospective observational study. SETTING University Medical Center Hamburg-Eppendorf, Hamburg, Germany, from April to October 2019. PATIENTS 49 patients scheduled for neurosurgery with AP measurement using a radial artery catheter. MAIN OUTCOME MEASURES We assessed the agreement between continuous noninvasive finger cuff-derived (CNAP Monitor 500; CNSystems Medizintechnik, Graz, Austria) and invasive AP measurements in a prospective method comparison study in patients having neurosurgery using all beat-to-beat AP measurements (Methodall), 10-s averages (Methodavg), one 30-min period of 10-s averages (Method30), Method30 with additional offset subtraction (Method30off), and 10 30-s periods without (Methodiso) or with (Methodiso-zero) application of the zero zone. The agreement was analysed using Bland-Altman and error grid analysis. RESULTS For mean AP, the mean of the differences (95% limits of agreement) was 9.0 (−12.9 to 30.9) mmHg for Methodall, 9.2 (−12.5 to 30.9) mmHg for Methodavg, 6.5 (−9.3 to 22.2) mmHg for Method30, 0.5 (−9.5 to 10.5) mmHg for Method30off, 4.9 (−6.0 to 15.7) mmHg for Methodiso, and 3.4 (−5.9 to 12.7) mmHg for Methodiso-zero. Similar trends were found for systolic and diastolic AP. Results of error grid analysis were also influenced by using different methods for data sampling and data processing. CONCLUSION Data sampling and data processing substantially impact the results of comparative statistics in method comparison studies of continuous AP monitoring systems. Depending on the method used for data sampling and data processing, the performance of an AP test method may be considered clinically acceptable or unacceptable.
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