Monnink Stefan H J, van Vliet Mariska, Kuiper Mathijs J, Constandse Jan C, Hoftijzer Dieke, Muller Marjolein, Ronner Eelko
Department of Cardiology, Reinier de Graaf Hospital, Reinier de Graafweg 5, Delft, The Netherlands.
Corsano Health B.V, Wilhelmina van Pruisenweg 35, The Hague, 2595 AN, The Netherlands.
J Clin Monit Comput. 2025 Apr;39(2):451-457. doi: 10.1007/s10877-024-01229-z. Epub 2024 Oct 10.
Recently, photoplethysmography-based vital parameter measurements have increased in popularity. However, clinical evaluation of these measurements is lacking. The objective of this study was to rigorously evaluate the clinical accuracy and reliability of a novel photoplethysmography-based wristband for measuring key vital parameters-oxygen saturation (SpO2), respiratory rate (RR), and pulse rate (PR)-during heart catheterisations. Vital parameters obtained during heart catheterisations by means of a photoplethysmography-based wristband (CardioWatch 287-2, Corsano Health) were compared to reference measurements performed by a Nellcor fingerclip (SpO2, PR) as well as a 5-lead ECG (RR) (QMAPP Haemodynamic Monitoring module, Fysicon B.V.) by means of correlation coefficients and root means squared error (RMSE). Effects of skin colour and arm hair density were additionally evaluated. In total, 945 samples from a total of 100 patients were included in the analysis. The correlation coefficients and RSME obtained for the difference between reference and photoplethysmography-based wristband measurements were r = 0.815 and 1.6% for SpO2, r = 0.976 and 0.9 brpm for RR, and r = 0.995 and 1.3 bpm for PR. Similar results were obtained across all skin colour and arm hair density subcategories. This study shows that photoplethysmography-based SpO2, RR, and PR measurements can be accurate during heart catheterisations. Future investigations are required to evaluate the wristband's performance under dynamic circumstances as well as over an extended time period. Trial registration: www.clinicaltrials.gov, NCT05566886.
最近，基于光电容积脉搏波描记法的生命体征参数测量越来越受欢迎。然而，这些测量的临床评估却很缺乏。本研究的目的是严格评估一种新型的基于光电容积脉搏波描记法的腕带在心脏导管插入术期间测量关键生命体征参数——血氧饱和度（SpO2）、呼吸频率（RR）和脉搏率（PR）——的临床准确性和可靠性。将通过基于光电容积脉搏波描记法的腕带（CardioWatch 287-2，Corsano Health）在心脏导管插入术期间获得的生命体征参数与通过Nellcor指夹（SpO2、PR）以及五导联心电图（RR）（QMAPP血流动力学监测模块，Fysicon B.V.）进行的参考测量结果通过相关系数和均方根误差（RMSE）进行比较。此外，还评估了肤色和手臂毛发密度的影响。总共100名患者的945个样本被纳入分析。参考测量值与基于光电容积脉搏波描记法的腕带测量值之间差异的相关系数和RSME分别为：SpO2的r = 0.815和1.6%，RR的r = 0.976和0.9次/分钟，PR的r = 0.995和1.3次/分钟。在所有肤色和手臂毛发密度子类别中都获得了类似的结果。本研究表明，基于光电容积脉搏波描记法的SpO2、RR和PR测量在心脏导管插入术期间可以是准确的。未来需要进行研究，以评估该腕带在动态情况下以及更长时间段内的性能。试验注册：www.clinicaltrials.gov，NCT05566886。
