1. Accuracy testing of a new optical device for noninvasive estimation of systolic and diastolic blood pressure compared to intra-arterial measurements
- Author
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Anna Vybornova, Bruce S. Alpert, Bastien De Marco, Cyril Pellaton, Valentin Chapuis, Olivier Grossenbacher, Josep Solà, Luisa Marques, Sibylle Fallet, and Mattia Bertschi
- Subjects
Adult ,Male ,medicine.medical_specialty ,genetic structures ,Systole ,Optical measurements ,Diastole ,030204 cardiovascular system & hematology ,Assessment and Diagnosis ,03 medical and health sciences ,0302 clinical medicine ,medicine.artery ,Internal medicine ,Catheterization, Peripheral ,Internal Medicine ,medicine ,Intra arterial ,Humans ,Arterial Pressure ,030212 general & internal medicine ,Radial artery ,Aged ,Aged, 80 and over ,Advanced and Specialized Nursing ,business.industry ,Limits of agreement ,Optical Devices ,Blood Pressure Determination ,General Medicine ,Middle Aged ,Wrist ,Arterial catheter ,Blood Pressure Monitors ,Blood pressure ,Radial Artery ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business ,Algorithms - Abstract
OBJECTIVE The objective of this study was to compare the systolic (S) and diastolic (D) blood pressure (BP) estimations from a new optical device at the wrist with invasive measurements performed on patients scheduled for radial arterial catheterization in the ICU. Optical signals were automatically processed by a library of algorithms from Aktiia SA (OBPM - optical blood pressure monitoring algorithms). METHODS A total of 31 participants from both sexes, aged 32-87 years, were enrolled in the study (NCT03837769). The measurement protocol consisted of the simultaneous recording of reflective photoplethysmographic signals (PPG) from the cuffless optical device and the reference BP values recorded by a contralateral radial arterial catheter. From the 31 participants, 23 subjects whose reference data quality requirements were adequate were retained for further analysis. The PPG signals from these patients were then automatically processed by the Aktiia OBPM library of algorithms, which generated uncalibrated estimates of SBP and DBP. After the automatic assessment of optical signal quality, 326 pairs of uncalibrated SBP and DBP determinations from 16 patients were available for analysis. These values were finally transformed into calibrated estimations (in mmHg) using arterial catheter SBP and DBP values, respectively. RESULTS For SBP, a mean difference (±SD) of 0.0 ± 7.1 mmHg between the arterial catheter and the optical device values was found, with 95% limits of agreement in the Bland-Altman method of -11.9 to + 12.2 mmHg (correlation of r = 0.87, P < 0.001). For DBP, a mean difference (±SD) of 0.0 ± 2.9 mmHg between arterial catheter and the optical device values was found, with 95% limits of agreement in the Bland-Altman method of -4.8 to + 5.5 mmHg (correlation of r = 0.98, P < 0.001). CONCLUSION SBP and DBP values obtained by radial artery catheterization and those obtained from optical measurements at the wrist were compared. The new optical technique appears to be capable of replacing more traditional methods of BP estimation.
- Published
- 2020
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