JMIR Publications

ABSTRACT

Background:

Wearable devices can provide user-friendly, accurate and continuous blood pressure (BP) monitoring to assess patients’ vital signs and achieve remote patients’ 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 measurements of a new device capturing PPG signal on the finger versus 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:

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 blood pressure monitoring. The diagnosis and treatment of hypertension should benefit from these advancements. Clinical Trial: Clinicaltrials.gov, NCT04379986. Registered on May 8, 2020