School of Nursing, McMaster University, Hamilton, ON, Canada.
Population Health Research Institute, Hamilton, ON, Canada.
JMIR Mhealth Uhealth. 2022 Feb 28;10(2):e24916. 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 duration of time).
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.
ClinicalTrials.gov NCT03493867; https://clinicaltrials.gov/ct2/show/NCT03493867.
可穿戴式连续监测生物传感器技术有可能通过早期发现即将发生的临床恶化来改变术后护理。
我们旨在验证 Cloud DX Vitaliti 连续生命体征监测仪（CVSM）连续无创血压（cNIBP）测量在术后患者中的准确性。次要目的是检查 Vitaliti CVSM 的用户接受度，包括舒适度、易用性、定位的可持续性和美观度。
纳入标准为年龄≥18 岁且正在心脏重症监护病房（ICU）接受手术恢复的患者。我们的目标是最多招募 80 名参与者进行验证和接受性测试。我们还进行了超额采样，以最大限度地减少研究中不可预见的中断和其他挑战的影响。验证程序符合国际标准化组织（ISO）81060-2：2018 标准，用于可穿戴式、无袖带血压（BP）测量设备。基线 BP 由金标准 ICU 动脉导管确定。Vitaliti CVSM 与参考动脉导管进行校准。在静态（卧床时坐立）和仰卧位，对每位患者使用 Vitaliti CVSM 和侵入性动脉导管进行 3 次 cNIBP 测量，每次 30 秒。在每个测试会话结束时，使用 MediCollector BEDSIDE 数据提取软件提取捕获的 cNIBP 测量值，并通过电缆连接将 Vitaliti CVSM 测量值提取到安全的笔记本电脑上。计算这些测定的误差。对患者进行了有关设备可接受性的访谈。
验证分析包括 20 名患者的数据。从校准到静态位置的第一次测量和到仰卧位的第一次测量的平均时间分别为 133.85 秒（2 分钟 14 秒）和 535.15 秒（8 分钟 55 秒）。静态位置的总体平均误差为收缩压（SBP）为-0.621（SD 4.640）mmHg，舒张压（DBP）为 0.457（SD 1.675）mmHg。仰卧位的误差稍高，SBP 为 2.722（SD 5.207）mmHg，DBP 为 2.650（SD 3.221）mmHg。大多数人认为 Vitaliti CVSM 很舒适。这项研究仅限于在设备校准后非常短的验证期内（即在校准后 2 分钟内开始，持续很短时间）评估设备。
我们发现，在评估开始后 2 分钟内进行的 Cloud DX 的 Vitaliti CVSM 符合 ISO 81060-2：2018 标准，测量连续无创血压（cNIBP）；该设备也在术后 ICU 环境中受到患者的好评。未来的研究将检查 Vitaliti CVSM 在动态环境中的准确性，注意评估时间的延长，以及患者过度运动对数据伪影和信号质量的影响。
ClinicalTrials.gov NCT03493867；https://clinicaltrials.gov/ct2/show/NCT03493867.
