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

Abstract

Background: Wearable continuous monitoring biosensor technologies have the potential to transform postoperative care with early detection of impending clinical deterioration.

Objective: 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.

Methods: 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.

Results: 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 duration of time).

Conclusions: We found that the Cloud DX's Vitaliti CVSM demonstrated cNIBP measurement in compliance with ISO 81060-2:2018 standards in the context of evaluation that commenced within 2 minutes of device calibration; this device was also well-received by patients in a postsurgical ICU setting. Future studies will examine the accuracy of the Vitaliti CVSM in ambulatory contexts, with attention to assessment over a longer duration and the impact of excessive patient motion on data artifacts and signal quality.

Trial registration: ClinicalTrials.gov NCT03493867; https://ichgcp.net/clinical-trials-registry/NCT03493867.

Keywords: accuracy; biosensor; blood pressure; continuous non-invasive blood pressure monitoring; continuous vital signs monitor; mHealth; monitoring; usability; validation; validation study; vital sign; wearable.

Conflict of interest statement

Conflicts of Interest: MHM and PJD are members of a research group that does not accept honorariums nor other payments from industry for personal financial gain. They do accept honorariums or payments from industry to support research endeavors and costs to participate in meetings. On the basis of study questions PJD has originated and grants he has written, he has received grants from Abbott Diagnostics, Boehringer Ingelheim, Covidien, Octapharma, Philips Healthcare, Roche Diagnostics, and Stryker. PJD has participated in a consultancy advisory board meeting for Boehringer Ingelheim. EBC has received grants from Roche Diagnostics, BMS-Pfizer, and Bayer. DC has received fees from Roche Diagnostics and BMS/Pfizer.

©Michael H McGillion, Nazari Dvirnik, Stephen Yang, Emilie Belley-Côté, Andre Lamy, Richard Whitlock, Maura Marcucci, Flavia K Borges, Emmanuelle Duceppe, Carley Ouellette, Marissa Bird, Sandra L Carroll, David Conen, Jean-Eric Tarride, Prathiba Harsha, Ted Scott, Amber Good, Krysten Gregus, Karla Sanchez, Pamela Benoit, Julian Owen, Valerie Harvey, Elizabeth Peter, Jeremy Petch, Jessica Vincent, Michelle Graham, P J Devereaux. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 28.02.2022.

Figures

Figure 1

The Vitaliti continuous vital signs monitor and user interface.

Figure 2

Study flow diagram.

Figure 3

Tri-axial accelerometer data showing static and then supine patient positions with overlaid 30-second measurement intervals.

Figure 4

Derivation of the study sample. BP: blood pressure; ECG: electrocardiogram; ISO: International Organization for Standardization.

Figure 5

Bland-Altman plot of systolic blood pressure determinants from the Vitaliti continuous vital signs monitor (CVSM) versus the arterial line in the static position.

Figure 6

Bland-Altman plot of diastolic blood pressure determinants from the Vitaliti continuous vital signs monitor (CVSM) versus the arterial line in the static position.

Figure 7

Bland-Altman plot of systolic blood pressure determinants from the Vitaliti continuous vital signs monitor (CVSM) versus the arterial line in the supine position.

Figure 8

Bland-Altman plot of diastolic blood pressure determinants from the Vitaliti continuous vital signs monitor (CVSM) versus the arterial line in the supine position.

Figure 9

Usability feedback. ECG: electrocardiogram.