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

Abstract

BackgroundWearable 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. ObjectiveThe 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. MethodsThe 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. ResultsPatient recruitment started in June 2021. Results are expected to be published by December 2021. ConclusionsThe findings of the Senbiosys trial are expected to improve remote BP monitoring. The diagnosis and treatment of hypertension should benefit from these advancements. Trial RegistrationClinicalTrials.gov NCT04379986; https://clinicaltrials.gov/ct2/show/NCT04379986 International Registered Report Identifier (IRRID)PRR1-10.2196/30051