JMIR Publications

ABSTRACT

Background:

Continuous hemodynamic monitoring is the standard of care for patients intraoperatively, but vital signs monitoring is performed only periodically on post-surgical wards, and patients are routinely discharged home with no surveillance. 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 the Cloud DX Vitaliti™ Continuous Vital Signs Monitor (CVSM) continuous non-invasive blood pressure (cNIBP) measurements in post-surgical 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 or older and were recovering from surgery in a cardiac intensive care unit. We targeted a maximum recruitment of 80 participants for verification and acceptance testing. We also over-sampled to minimize the effect of unforeseen interruptions and other challenges to the study. Validation procedures were according to –International Standards Organization (ISO) 81060-2 2018 standards for Wearable, Cuffless Blood Pressure Measuring Devices. Baseline blood pressure was determined from the gold-standard ICU arterial catheter, and the Vitaliti™ CVSM was calibrated against the reference arterial catheter. In static (seated in bed) and supine positions, three 30-second cNIBP measurements 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, including comfort and aesthetics.

Results:

Data for 20 patients were included in the validation analysis. The average time elapsed from calibration to first measurement in the static position and first measurement in the supine position was 133.85 seconds (2min14sec), 535.15 seconds (8min55sec), respectively. The overall mean and SD of the errors of determination for the static position were -0.621 mmHg (SD 4.640) for systolic blood pressure and 0.457 mmHg (SD 1.675) for diastolic blood pressure. Errors of determination were slightly higher for the supine position at 2.722 mmHg (SD 5.207) for systolic blood pressure and 2.650 mmHg (SD 3.221) for diastolic blood pressure. The majority rated the Vitaliti™ CVSM as comfortable.

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 of the impact of excessive patient motion on data artifacts and signal quality. Clinical Trial: ClinicalTrials.gov (NCT03493867)