| Abstrakt: |
Purpose: To determine the acceptability of the ClearSight™ system (Edwards Lifesciences Corp., Irvine, CA, USA) for continuous blood pressure monitoring during elective cardiac surgery compared with arterial catheterization. Methods: We enrolled 30 patients undergoing elective cardiac surgery in a prospective observational study. Blood pressure measurements were recorded every 10 sec intraoperatively. We determined agreement based on the Association for the Advancement of Medical Instrumentation (AAMI) recommendations. Statistical analysis included fixed bias (difference of measurements between methods), percentage error (accuracy between ClearSight measurement and expected measurement from arterial line), and interchangeability (ability to substitute ClearSight monitor without effecting overall outcome of analysis). We used a paired samples ttest to compare the time required for placing each monitor. Results: We found fixed bias in the differences between the ClearSight monitor and invasive arterial blood pressure measurement in systolic blood pressure (SBP; mean difference, 8.7; P< 0.001) and diastolic blood pressure (DBP; mean difference, −2.2; P< 0.001), but not in mean arterial pressure (MAP; mean difference, −0.5; P< 0.001). Bland–Altman plots showed that the means of the limits of agreement were greater than 5 mm Hg for SBP, DBP, and MAP. The percentage errors for SBP, DBP, and MAP were lower than the cutoff we calculated from the invasive arterial blood pressure measurements. Average interchangeability rates were 38% for SBP, 50% for DBP, and 50% for MAP. Placement of the ClearSight finger cuff was significantly faster compared with arterial catheterization (mean [standard deviation], 1.7 [0.6] min vs5.6 [4.1] min; P< 0.001). Conclusions: In this prospective observational study, we did not find the ClearSight system to be an acceptable substitute for invasive arterial blood pressure measurement in elective cardiac surgery patients according to AAMI guidelines. Nevertheless, based on statistical standards, there is evidence to suggest otherwise. Study registration: ClinicalTrials.gov (NCT05825937); first submitted 11 April 2023. |
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