Clinical trial NCT03837769: Validation of the Aktiia SA PulseWatch OBPM Device at the Wrist Against Invasive Blood Pressure Measurements
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: Blood Pressure
OBPM
Cuffless
Lead sponsor: Hopital Neuchatelois
Sponsor class: OTHER
Collaborators: name: Aktiia SA
First posted: 2019-02-12
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

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

Primary outcomes:
measure: Cuffless Blood Pressure performance
timeFrame: 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Neuchâtel
country: Switzerland
facility: Hôpital neuchâtelois - Pourtalès
Study officials:
References: