Accuracy testing of a new optical device for noninvasive estimation of systolic and diastolic blood pressure compared to intra-arterial measurements.

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.

Performance Assessment of a Dedicated Reflectance Pulse Oximeter in a Neonatal Intensive Care Unit.

The measurement of peripheral oxygen saturation (SpO2) in neonatal intensive care units (NICUs) poses a significant challenge. Motion artifacts due to the patient's limb motion induce many false alarms, which in turn cause an additional workload for the medical staff and anxiety for the parents. We developed a reflectance pulse oximeter dedicated to be placed at the patient's forehead, which is less prone to such artifacts. We trained our algorithms for SpO2 estimation on 8 adult healthy volunteers participating in a controlled desaturation study. We then validated our SpO2 monitoring system on 25 newborn patients monitored in an NICU. We further evaluated the versatility and resilience to low signal-tonoise ratios (SNR) of our solution by testing it on signals acquired in a low-perfusion region (upper right part of the chest) of our adult volunteers. We obtained an SpO2 estimation accuracy ($A _{\mathbf {rms}}$) of 1.9 % and 3.1 % at the forehead and the chest in our adult volunteers, respectively. These performances were obtained after automatic rejection of 0.1 % and 30.0 %, respectively, of low-SNR signals by our dedicated quality index. In the dataset recorded on newborn patients in the NICU, we obtained an accuracy of 3.9 % after automatic rejection of 11.7 % of low-SNR signals by our quality index. These analyses were carried out following the procedures suggested by the ISO 80601-2-61:2011 standard, which specifies a target $A _{\mathbf {rms}} \le $ 4 % for SpO2 monitoring applications. These promising results suggest that reflectance pulse oximeters can achieve clinically acceptable accuracy, while being placed at locations less sensitive to limb motion artifacts - such as the forehead - thereby reducing the amount of SpO2-related false alarms in NICUs.

Clinical validation of LTMS-S: A wearable system for vital signs monitoring.

LTMS-S is a new wearable system for the monitoring of several physiological signals--including a two-lead electrocardiogram (ECG)--and parameters, such as the heart rate, the breathing rate, the peripheral oxygen saturation (SpO2), the core body temperature (CBT), and the physical activity. All signals are measured using only three sensors embedded within a vest. The sensors are standalone with their own rechargeable battery, memory, wireless communication and with an autonomy exceeding 24 hours. This paper presents the results of the clinical validation of the LTMS-S system.

Noninvasive and Nonocclusive Blood Pressure Estimation Via a Chest Sensor.

The clinical demand for a device to monitor blood pressure (BP) in ambulatory scenarios with minimal use of inflation cuffs is increasing. Based on the so-called pulse wave velocity (PWV) principle, this paper introduces and evaluates a novel concept of BP monitor that can be fully integrated within a chest sensor. After a preliminary calibration, the sensor provides nonocclusive beat-by-beat estimations of mean arterial pressure (MAP) by measuring the pulse transit time (PTT) of arterial pressure pulses travelling from the ascending aorta toward the subcutaneous vasculature of the chest. In a cohort of 15 healthy male subjects, a total of 462 simultaneous readings consisting of reference MAP and chest PTT were acquired. Each subject was recorded at three different days: D, D+3, and D+14. Overall, the implemented protocol induced MAP values to range from 80 ± 6 mmHg in baseline, to 107 ± 9 mmHg during isometric handgrip maneuvers. Agreement between reference and chest-sensor MAP values was tested by using intraclass correlation coefficient (ICC = 0.78) and Bland-Altman analysis (mean error = 0.7 mmHg, standard deviation = 5.1 mmHg). The cumulative percentage of MAP values provided by the chest sensor falling within a range of ±5 mmHg compared to reference MAP readings was of 70%, within ±10 mmHg was of 91%, and within ±15 mmHg was of 98%. These results point at the fact that the chest sensor complies with the British Hypertension Society requirements of Grade A BP monitors, when applied to MAP readings. Grade A performance was maintained even two weeks after having performed the initial subject-dependent calibration. In conclusion, this paper introduces a sensor and a calibration strategy to perform MAP measurements at the chest. The encouraging performance of the presented technique paves the way toward an ambulatory compliant, continuous, and nonocclusive BP monitoring system.