Validation of the Aktiia SA PulseWatch OBPM Device at the Wrist Against Invasive Blood Pressure Measurements

Launched by HOPITAL NEUCHATELOIS · Feb 8, 2019

Keywords

ClinConnect Summary

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 a...

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Eligibility criteria

• Inclusion criteria:
• • Age ≥ 18 years
• • No significant non-invasive systolic blood pressure difference between left arm and right arm (difference \<20mmHg in systolic arterial pressure)
• • Patient requires continuous monitoring of diastolic and systolic blood pressure continuously via a radial arterial line;
• • Patient information and informed consent is obtained following the procedures described in CIP
• Exclusion criteria:
• • Arrythmias: tachycardia (resting heart rate \> 120/min) at time of study inclusion
• • Atrial fibrillation
• • Psychomotor agitation
• • Significant bruises or trauma on forearm
• • Intravenous canula around the wrist with impossibility to place the device (Aktiia OBPM PulseWatch) around the wrist