Provincial Department of Anesthesiology, College of Medicine, University of Saskatchewan, Saskatoon, SK, Canada.
Department of Surgery, College of Medicine, University of Saskatchewan, Saskatoon, SK, Canada.
Can J Anaesth. 2024 Nov;71(11):1495-1504. doi: 10.1007/s12630-024-02834-x. Epub 2024 Sep 24.
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.
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 t test to compare the time required for placing each monitor.
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 vs 5.6 [4.1] min; P < 0.001).
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.
ClinicalTrials.gov ( NCT05825937 ); first submitted 11 April 2023.
与动脉导管相比，确定用于监测择期心脏手术期间连续血压的 ClearSight™系统（美国加利福尼亚州欧文市爱德华兹生命科学公司）的可接受性。
我们在一项前瞻性观察研究中纳入了 30 名接受择期心脏手术的患者。术中每 10 秒记录一次血压测量值。我们根据医疗器械促进协会 (AAMI) 的建议确定了一致性。统计分析包括固定偏差（两种方法测量值之间的差异）、百分比误差（ClearSight 测量值与动脉线预期测量值之间的准确性）和可互换性（能够替代 ClearSight 监护仪而不影响分析结果的总体效果）。我们使用配对样本 t 检验比较了放置每个监护仪所需的时间。
我们发现 ClearSight 监护仪与侵入性动脉血压测量之间的差异存在固定偏差，在收缩压（SBP；平均差值，8.7；P<0.001）和舒张压（DBP；平均差值，-2.2；P<0.001）中，但在平均动脉压（MAP；平均差值，-0.5；P<0.001）中没有。Bland-Altman 图显示，协议限的平均值大于 SBP、DBP 和 MAP 的 5 mmHg。SBP、DBP 和 MAP 的百分比误差低于我们从侵入性动脉血压测量中计算出的截止值。SBP 的平均可互换率为 38%，DBP 为 50%，MAP 为 50%。与动脉导管相比，ClearSight 手指袖带的放置速度明显更快（平均[标准差]，1.7[0.6] 分钟比 5.6[4.1] 分钟；P<0.001）。
在这项前瞻性观察研究中，根据 AAMI 指南，我们并未发现 ClearSight 系统可作为择期心脏手术患者侵入性动脉血压测量的可接受替代方法。然而，根据统计标准，有证据表明并非如此。
ClinicalTrials.gov（NCT05825937）；首次提交于 2023 年 4 月 11 日。
