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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Blood Pressure

Intervention / Treatment
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* Device: Aktiia OBPM PulseWatch wrist device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aktiia SA PulseWatch<br>Aktiia OBPM PulseWatch wrist device | Device: Aktiia OBPM PulseWatch wrist device<br>* The optical signals at the wrist are recorded non-invasively. The BP measurements are further determined from these optical signals and are compared to the reference BP readings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cuffless Blood Pressure performance | The evaluation of the accuracy (mean error and standard deviation of the error) of the non-invasive BP measurements at wrist with the PulseWatch against the reference gold-standard invasive blood pressure obtained by arterial line with respect to ISO 81060-2 (14) for two aspects: i) capturing the variations of the BP in short time and ii) maintaining the accurate stable measurements over extended periods of time. | 4 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Pressure, OBPM, Cuffless