Continuous Noninvasive Remote Automated Blood Pressure Monitoring With Novel Wearable Technology: A Preliminary Validation Study

• Published in: JMIR mHealth and uHealth 2022-02, Vol.10 (2), p.e24916-e24916
• Main Authors: McGillion, Michael H, Dvirnik, Nazari, Yang, Stephen, Belley-Côté, Emilie, Lamy, Andre, Whitlock, Richard, Marcucci, Maura, Borges, Flavia K, Duceppe, Emmanuelle, Ouellette, Carley, Bird, Marissa, Carroll, Sandra L, Conen, David, Tarride, Jean-Eric, Harsha, Prathiba, Scott, Ted, Good, Amber, Gregus, Krysten, Sanchez, Karla, Benoit, Pamela, Owen, Julian, Harvey, Valerie, Peter, Elizabeth, Petch, Jeremy, Vincent, Jessica, Graham, Michelle, Devereaux, P J
• Format: Article
• Language: English
• Subjects: Adolescent; Automation; Blood pressure; Blood Pressure - physiology; Blood Pressure Determination; Catheters; Clinical deterioration; Electrocardiography; Heart rate; Heart surgery; Hospitals; Humans; Hypotension; ISO standards; Medical equipment; Monitoring, Physiologic; Original Paper; Patients; Vital signs; Wearable computers; Wearable Electronic Devices
• ISSN: 2291-5222; 2291-5222
• DOI: 10.2196/24916

Wearable continuous monitoring biosensor technologies have the potential to transform postoperative care with early detection of impending clinical deterioration. Our aim was to validate the accuracy of Cloud DX Vitaliti continuous vital signs monitor (CVSM) continuous noninvasive blood pressure (cNIBP) measurements in postsurgical patients. A secondary aim was to examine user acceptance of the Vitaliti CVSM with respect to comfort, ease of application, sustainability of positioning, and aesthetics. Included participants were ≥18 years old and recovering from surgery in a cardiac intensive care unit (ICU). We targeted a maximum recruitment of 80 participants for verification and acceptance testing. We also oversampled to minimize the effect of unforeseen interruptions and other challenges to the study. Validation procedures were according to the International Standards Organization (ISO) 81060-2:2018 standards for wearable, cuffless blood pressure (BP) measuring devices. Baseline BP was determined from the gold-standard ICU arterial catheter. The Vitaliti CVSM was calibrated against the reference arterial catheter. In static (seated in bed) and supine positions, 3 cNIBP measurements, each 30 seconds, were taken for each patient with the Vitaliti CVSM and an invasive arterial catheter. At the conclusion of each test session, captured cNIBP measurements were extracted using MediCollector BEDSIDE data extraction software, and Vitaliti CVSM measurements were extracted to a secure laptop through a cable connection. The errors of these determinations were calculated. Participants were interviewed about device acceptability. The validation analysis included data for 20 patients. The average times from calibration to first measurement in the static position and to first measurement in the supine position were 133.85 seconds (2 minutes 14 seconds) and 535.15 seconds (8 minutes 55 seconds), respectively. The overall mean errors of determination for the static position were -0.621 (SD 4.640) mm Hg for systolic blood pressure (SBP) and 0.457 (SD 1.675) mm Hg for diastolic blood pressure (DBP). Errors of determination were slightly higher for the supine position, at 2.722 (SD 5.207) mm Hg for SBP and 2.650 (SD 3.221) mm Hg for DBP. The majority rated the Vitaliti CVSM as comfortable. This study was limited to evaluation of the device during a very short validation period after calibration (ie, that commenced within 2 minutes after calibration and lasted for a short dur