Blood pressure from the optical Aktiia Bracelet: a 1-month validation study using an extended ISO81060-2 protocol adapted for a cuffless wrist device.

Details

Serval ID
serval:BIB_BA2EAD93F0A5
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Blood pressure from the optical Aktiia Bracelet: a 1-month validation study using an extended ISO81060-2 protocol adapted for a cuffless wrist device.
Journal
Blood pressure monitoring
Author(s)
Vybornova A., Polychronopoulou E., Wurzner-Ghajarzadeh A., Fallet S., Sola J., Wuerzner G.
ISSN
1473-5725 (Electronic)
ISSN-L
1359-5237
Publication state
Published
Issued date
01/08/2021
Peer-reviewed
Oui
Volume
26
Number
4
Pages
305-311
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Abstract
The objective of this study (NCT04027777) was to assess the accuracy and precision of the Aktiia Bracelet, a CE-marked noninvasive optical blood pressure (BP) monitor worn at the wrist, over a period of 1 month.
In this study, participants aged between 21 and 65 years were recruited. The clinical investigation extended the ISO81060-2:2013 standard to the specificities of cuffless devices. Each BP assessment consisted of the simultaneous recording of optical signals with Aktiia Bracelet and double-blinded auscultation by two trained observers in the standard sitting position. The algorithms of Aktiia Bracelet further processed the recorded optical signals to perform a signal quality check and to calculate uncalibrated estimates of systolic BP (SBP) and diastolic BP (DBP). These estimates were transformed into mmHg using a subject-dependent calibration parameter, which was calculated using the first two available reference measurements per subject.
Eighty-six participants were included in the analysis. The mean and SD of the differences between Aktiia Bracelet estimates and the reference (ISO81060-2 criterion 1) were 0.46 ± 7.75 mmHg for SBP and 0.39 ± 6.86 mmHg for DBP. The SD of the averaged paired difference per subject (ISO81060-2 criterion 2) were 3.9 mmHg for SBP and 3.6 mmHg for DBP.
After initialization and during 1 month, the overall accuracy of Aktiia Bracelet satisfied validation criteria 1 and 2 of ISO81060-2 in the sitting position. The Aktiia Bracelet can be recommended for BP measurement in the adult population.
Keywords
Adult, Aged, Auscultation, Blood Pressure, Blood Pressure Determination, Blood Pressure Monitors, Humans, Middle Aged, Wrist, Young Adult
Pubmed
Web of science
Open Access
Yes
Create date
16/03/2021 9:42
Last modification date
24/07/2021 6:34
Usage data