Development and Implementation of Continuous Blood Pressure Monitoring: A Study Utilizing Photoplethysmography (PPG) Sensor Technology.

The primary endpoint of the study is the technical performance verification of

a PPG-based algorithm for continuous one-minute SBP and DBP values derived from

viQtor data, meeting standards set by the Association for the Advancement of

Medical Instrumentation (AAMI). This is deemed acceptable for clinical purposes

if the mean absolute error (MAE) <= 5 mmHg and the standard deviation (SD) of

the difference <= 8 mmHg between simultaneously paired measurements from viQtor

SQ-RD and the arterial line (White et al., 1993).

8.1.2 Secondary study parameters/endpoints

• Evaluate whether viQtor*s BP data adheres to at least Grade B of the BHS

standard.

o For clinical acceptability (minimum Grade B), the MEA and distribution of the

MAE between simultaneously paired measurements of both DBP and SBP between the

viQtor SQ-RD and the arterial line adhere to the following criteria.

Additionally, it is essential that at least 20% of these one-minute median BP

measurements obtained by the viQtor SQ-RD are available:

* <= 5 mmHg for 60% of the paired measurements (Grade A);

* <= 10 mmHg for 85% of the paired measurements (Grade A);

* <= 15 mmHg for 95% of the paired measurements (Grade A);

* <= 5 mmHg for 50% of the paired measurements (Grade B);

* <=10 mmHg for 75% of the paired measurements (Grade B);

* <=15 mmHg for 90% of the paired measurements (Grade B).



• Evaluate whether viQtor*s BP measurements meet the accuracy requirements of

the 81060-2:2022 standard (ISO, 2018).

o For clinical acceptability, the MEA and SD between simultaneously paired

systolic and diastolic BP measurements must adhere to the following criteria

set by the 81060-2:2022 standard: Acceptable for clinical purposes if the MAE

is <= 5 mmHg and the SD is <= 8 mmHg between simultaneously paired measurements

from viQtor SQ-RD and the arterial line (ISO, 2018).



• Descriptive, MAE and SD between simultaneously paired measurements of mean

arterial pressure (MAP) from viQtor SQ-RD and the arterial line.

o Acceptable for clinical purposes if MAE < 6 mmHg and SD is < 10 mmHg between

simultaneously paired measurements from viQtor SQ-RD and the arterial line.



• Descriptive, ARMS between paired one-minute median values of DBP and SBP

values estimated using a 2-point model-based method (using ear PPG and viQtor

PPG) and invasive arterial line, in accordance with the AAMI standards (White

et al., 1993).

o Acceptable for clinical purposes if the MAE <= 5 mmHg and the SD of the

difference between the estimated DBP and SBP values of the model and the

arterial line is <= 8 mmHg (White et al., 1993).



• Comparison of ARMS and other relevant statistical outcomes between viQtor

SQ-RD and the invasive arterial line, and between the 2-point model-based

method and invasive arterial line.



• Descriptive, ARMS between simultaneously paired measurements of SpO2 from

viQtor SQ-RD and ear SpO2 measurements from the Philips IntelliVue MX750

monitor.

o Acceptable for clinical purposes if the total ARMS is within 2%.



• Descriptive ARMS between simultaneously paired measurements of SpO2 from

viQtor SQ-RD and SaO2 from blood gasses of the arterial line.

o Acceptable for clinical purposes if the total ARMS is within 2%.



• Descriptive, ARMS between simultaneously paired measurements of Heart Rate

(HR) from viQtor SQ-RD and ECG-based of the Philips IntelliVue MX750 monitor.

o Acceptable for clinical purposes if the total ARMS is within +/- 3 beats/min.



• Descriptive, ARMS between simultaneously paired measurements of Respiratory

Rate (RR) from viQtor SQ-RD and Capnography of the Philips IntelliVue MX750

monitor.

o Acceptable for clinical purposes if the total ARMS is within +/- 3

breaths/min.



• Descriptive, ARMS between simultaneously paired measurements of MAP, DBP and

SBP values from the viQtor SQ-RD and the cuff-based sphygmomanometers.

o Acceptable for clinical purposes if the MAE <= 5 mmHg and the SD of the

difference is <= 8 mmHg between the simultaneously paired measurements from

viQtor SQ-RD and the cuff-based measurements (White et al., 1993).



• Evaluate the correlation and the ability for prediction of treatment related

complications with the absolute measurements and trends from the various

non-invasive measured parameters with the viQtor SQ-RD and the occurrence.