Validation of the Aktiia SA PulseWatch OBPM Device at the Wrist Against Invasive Blood Pressure Measurements (OBPM_ICU2018)
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|ClinicalTrials.gov Identifier: NCT03837769|
Recruitment Status : Completed
First Posted : February 12, 2019
Last Update Posted : June 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Blood Pressure||Device: Aktiia OBPM PulseWatch wrist device||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|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|
|Actual Study Start Date :||February 12, 2019|
|Actual Primary Completion Date :||May 22, 2019|
|Actual Study Completion Date :||May 31, 2019|
Experimental: Aktiia SA PulseWatch
Aktiia OBPM PulseWatch wrist device
Device: Aktiia OBPM PulseWatch wrist device
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.
- Cuffless Blood Pressure performance [ Time Frame: 4 Months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837769
|Hôpital neuchâtelois - Pourtalès|
|Neuchâtel, Switzerland, 2000|