Remote Blood Pressure Monitoring With a Wearable Photoplethysmographic Device (Senbiosys): Protocol for a Single-Center Prospective Clinical Trial

Sara Schukraft; Assim Boukhayma; Stéphane Cook; Antonino Caizzone

doi:10.2196/30051

Remote Blood Pressure Monitoring With a Wearable Photoplethysmographic Device (Senbiosys): Protocol for a Single-Center Prospective Clinical Trial

JMIR Res Protoc. 2021 Oct 7;10(10):e30051. doi: 10.2196/30051.

Authors

Sara Schukraft¹, Assim Boukhayma², Stéphane Cook¹, Antonino Caizzone²

Affiliations

¹ Department of Cardiology, University and Hospital Fribourg, Fribourg, Switzerland.
² Microcity Pôle d'innovation Neuchâtel, Neuchâtel, Switzerland.

PMID: 34617912
PMCID: PMC8532013
DOI: 10.2196/30051

Abstract

Background: Wearable devices can provide user-friendly, accurate, and continuous blood pressure (BP) monitoring to assess patients' vital signs and achieve remote patient management. Remote BP monitoring can substantially improve BP control. The newest cuffless BP monitoring devices have emerged in patient care using photoplethysmography.

Objective: The Senbiosys trial aims to compare BP measurements of a new device capturing a photoplethysmography signal on the finger versus invasive measurements performed in patients with an arterial catheter in the intensive care unit (ICU) or referred for a coronarography at the Hospital of Fribourg.

Methods: The Senbiosys study is a single-center, single-arm, prospective trial. The study population consists of adult patients undergoing coronarography or patients in the ICU with an arterial catheter in place. This study will enroll 35 adult patients, including 25 patients addressed for a coronarography and 10 patients in the ICU. The primary outcome is the assessment of mean bias (95% CI) for systolic BP, diastolic BP, and mean BP between noninvasive and invasive BP measurements. Secondary outcomes include a reliability index (Qualification Index) for BP epochs and count of qualified epochs.

Results: Patient recruitment started in June 2021. Results are expected to be published by December 2021.

Conclusions: The findings of the Senbiosys trial are expected to improve remote BP monitoring. The diagnosis and treatment of hypertension should benefit from these advancements.

Trial registration: ClinicalTrials.gov NCT04379986; https://clinicaltrials.gov/ct2/show/NCT04379986.

International registered report identifier (irrid): PRR1-10.2196/30051.

Keywords: Senbiosys; arterial line; blood pressure; continuous blood pressure monitoring; continuous monitoring; mHealth; mobile health; photoplethysmography; remote monitoring; wearable devices.

©Sara Schukraft, Assim Boukhayma, Stéphane Cook, Antonino Caizzone. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 07.10.2021.

Associated data

ClinicalTrials.gov/NCT04379986