Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 29, 2021
Date Accepted: Jul 26, 2021
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Remote blood pressure monitoring with the wearable SENBIOSYS photoplethysmographic device: study protocol for a single-center, prospective clinical trial
ABSTRACT
Background:
Wearable devices can provide user-friendly, accurate and continuous blood pressure (BP) monitoring to assess patient's vital signs and achieve remote patient’s management. Remote blood pressure monitoring can significantly improve blood pressure control. The newest cuff-less blood pressure monitoring devices have emerged in patient care using photoplethysmography (PPG).
Objective:
The Senbiosys trial aims to compare BP measurement of a new device capturing PPG signal on the finger with invasive measurements performed in patients with an arterial catheter in 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 patient in the ICU with an arterial catheter in place. The current study will enrol 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 blood pressure (SBP), diastolic blood pressure (DBP) and mean blood pressure (MBP) between non-invasive and invasive BP measurements. Secondary outcomes include reliability index (Qualification Index QI) for blood pressure epochs and count of qualified epochs.
Results:
Recruitment will start in Mai 2021. Preliminary results are expected to be available by August 2021.
Conclusions:
Findings to the Senbiosys trial are expected to improve remote blood pressure monitoring. The diagnosis and treatment of hypertension should benefit from these advancements. Clinical Trial: Clinicaltrials.gov, NCT04379986. Registered on May 8, 2020
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