Blood Pressure Clinical Trial
Official title:
Single-center Intervention Study to Validate the Performance of the Aktiia SA PulseWatch Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Invasive Blood Pressure Measurements With Arterial Line
Single-centre intervention study to validate the performance of the Aktiia SA optical blood pressure monitoring (OBPM) device at the wrist against invasive blood pressure measurements with arterial line.
Aktiia SA PulseWatch is an investigational device for the optical measurement of blood
pressure that uses only optical sensors at the wrist. HNE is interested in exploring the
potential of the device and technology (OBPM), and aims at benchmarking its performances
against gold standard measurements of blood pressure.
The goal of this study is thus to assess whether i) PulseWatch allows to capture blood
pressure variations, and ii) the measured blood pressure values remain stable in time.
The proposed study plans to include patients that are already scheduled for arterial
catheterization at HNE. For these patients, the study will only require the placement of the
safe optical device on the wrist to non-invasively record hemodynamic fluctuations.
Therefore, no additional risk for the patient is to be foreseen.
By demonstrating that the Aktiia SA OBPM technology is reliable, HNE aims to make one step
further in improving blood pressure monitoring in general, and in particular in advancing the
deployment of technologies that have the potential to be used in the ambulatory setting. The
diagnosis and treatment of hypertension are expected to largely benefit from these
advancements.
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