Clinical trial confirms accuracy of Aktiia’s cuffless blood pressure technology

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04.11.2019
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Aktiia has concluded the analysis of the data of a clinical trial comparing cuffless optical blood pressure measurements at the wrist against invasive references. The results have been published in the peer-reviewed journal Blood Pressure Monitoring, with the conclusion that Aktiia’s optical technology is capable of replacing more traditional methods of blood pressure measurement such as cuffs.

Since its incorporation in 2018, Aktiia has focused on the development of a library of algorithms for the continuous 24/7 monitoring of blood pressure. The Aktiia algorithms only require input Signals acquired from off-the-shelf optical sensors at the wrist: the same sensors that are today used in wearable deviues to measure heart rate. This technology is expected to be a key element for the deployment of cuffless devices for the 24/7 monitoring of blood pressure.

The idea of an algorithm for cuffless blood pressure monitoring that processes Signals from optical sensors has been explored in the past. However, the performance of existing Solutions has only been partially assessed, or has been tested in very controlled conditions against dubious reference measurements. Aktiia believes that the development and further deployment of cuffless blood pressure technologies requires thorough experimental investigations involving measurement of ground-truth blood pressure values, including invasive measurements. Intensive care units represent an ethical and compelling environment for such investigations.

In February 2019, Aktiia SA joined efforts with Dr. Cyril Pellaton and his team in the Höpital Neuchätelois, Neuchätel, Switzerland, to initiate a clinical trial. After approval from Swissmedic and the local Ethical Committee, the investigators enrolled 30 critical patients elected for radial arterial catherization at the intensive care unit. After inclusion, the team recorded ground-truth blood pressure measurements at the radial artery simultaneously to optical Signals acquired at the contralateral wrist by a prototype of the Aktiia wearable device.

Today, Dr. Pellaton and Aktiia SA announce the conclusion of the analysis of the compiled data and its publication in the peer-reviewed journal Blood Pressure Monitoring. The obtained results provide clear and compelling evidence on the reliability and accuracy of the OBPM technology compared to currently acoepted methuds of blood pressure measurement. This is a major milestone in the clinical activities of Company, contributing toward the company’s mission to bring easy, painless blood pressure monitoring to daily life.

The study

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 catherization in the intensive care unit (ICU). Optical Signals were automatically processed by a library of algorithms from Aktiia SA (OBPM – Optical Blood Pressure Monitoring algorithms).

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 photo-plethysmographic Signals (PPG) from the cuffless optical device and the reference blood pressure 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

The clinical Standard for blood pressure measurement accuracy requires the Standard deviation of the error between a new device and a reference device to be less than 8mmHg In this study, for SBP, the results showed a Standard deviation of 7.1 mmHg between the Aktiia optical device and the arterial catheter used as reference. For DBP the results were even more accurate, with a Standard deviation of 2 9 mmHg Additionally, and utilizing the criteria for results that are considered statistically highly significant (P <0.001, i.e less than one in a thousand Chance of being wrong), we observed a correlation coefficient between reference and Aktiia measurements of r = 0.87 for SBP, and of r = 0.98 for DBP. This shows very strong correlation in both cases, with superb correlation for DBP (very close to r=1, i.e a perfect linear relationship).

(Press release)

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