Newly Published
Perioperative Medicine  |   November 2019
Vital Signs Monitoring with Wearable Sensors in High-risk Surgical Patients: A Clinical Validation Study
Author Notes
  • From the Department of Anesthesiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands (M.J.M.B., E.J.K., K.v.L., C.J.K.); FocusCura, Driebergen-Rijsenburg, The Netherlands (M.J.M.B., D.A.J.D.); Department of Technical Medicine, University of Twente, Enschede, The Netherlands (E.J.K.); Department of Trauma Surgery (L.P.H.L.) and Department of Gastrointestinal and Oncologic Surgery (R.v.H., J.P.R.), University Medical Center Utrecht, Utrecht, The Netherlands (L.P.H.L.); and Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands (T.J.B.).
  • The work presented in this article had an abstract discussion at the Annual Conference of Anesthesiology in San Francisco, California, October 15, 2018.
    The work presented in this article had an abstract discussion at the Annual Conference of Anesthesiology in San Francisco, California, October 15, 2018.×
  • Submitted for publication January 24, 2019. Accepted for publication September 18, 2019.
    Submitted for publication January 24, 2019. Accepted for publication September 18, 2019.×
  • Correspondence: Address correspondence to Ms. Breteler: University Medical Center Utrecht, Mail Stop Q.04.2.313, P.O. Box 85500, 3508 GA Utrecht, The Netherlands. m.j.m.breteler@umcutrecht.nl. Information on purchasing reprints may be found at www.anesthesiology.org or on the masthead page at the beginning of this issue. Anesthesiology’s articles are made freely accessible to all readers, for personal use only, 6 months from the cover date of the issue.
Article Information
Perioperative Medicine / Technology / Equipment / Monitoring
Perioperative Medicine   |   November 2019
Vital Signs Monitoring with Wearable Sensors in High-risk Surgical Patients: A Clinical Validation Study
Anesthesiology Newly Published on November 13, 2019. doi:https://doi.org/10.1097/ALN.0000000000003029
Anesthesiology Newly Published on November 13, 2019. doi:https://doi.org/10.1097/ALN.0000000000003029
Abstract

Editor’s Perspective:

What We Already Know about This Topic:

  • Changes in vital signs are an important indicator of physiological decline and hence provide opportunities for early recognition and intervention; however, in the hospital ward, vital signs are usually measured intermittently. In between such spot checks, early signs of deterioration may be missed.

  • Several “wearable” and wireless sensors have been developed that may capture the patient deterioration earlier.

What This Article Tells Us That Is New:

  • In high-risk surgical patients admitted to a step-down unit, heart rate was accurately measured by the two wearable patch sensors (SensiumVitals [Sensium Healthcare Ltd., United Kingdom] and HealthPatch [VitalConnect, United States]) and by the bed-based contactless mattress sensor (EarlySense [EarlySense Ltd., Israel]) and by the patient-worn monitor (Masimo Radius-7 [Masimo Corporation, United States]). The highest precision for heart rate was seen with the HeathPatch sensor.

  • For respiratory rate, the accuracies of the Masimo Radius-7, EarlySense, and SensiumVitals were within a predefined acceptable range, while the HealthPatch overestimated respiratory rate.

Background: Vital signs are usually recorded once every 8 h in patients at the hospital ward. Early signs of deterioration may therefore be missed. Wireless sensors have been developed that may capture patient deterioration earlier. The objective of this study was to determine whether two wearable patch sensors (SensiumVitals [Sensium Healthcare Ltd., United Kingdom] and HealthPatch [VitalConnect, United States]), a bed-based system (EarlySense [EarlySense Ltd., Israel]), and a patient-worn monitor (Masimo Radius-7 [Masimo Corporation, United States]) can reliably measure heart rate (HR) and respiratory rate (RR) continuously in patients recovering from major surgery.

Methods: In an observational method comparison study, HR and RR of high-risk surgical patients admitted to a step-down unit were simultaneously recorded with the devices under test and compared with an intensive care unit–grade monitoring system (XPREZZON [Spacelabs Healthcare, United States]) until transition to the ward. Outcome measures were 95% limits of agreement and bias. Clarke Error Grid analysis was performed to assess the ability to assist with correct treatment decisions. In addition, data loss and duration of data gaps were analyzed.

Results: Twenty-five high-risk surgical patients were included. More than 700 h of data were available for analysis. For HR, bias and limits of agreement were 1.0 (–6.3, 8.4), 1.3 (–0.5, 3.3), –1.4 (–5.1, 2.3), and –0.4 (–4.0, 3.1) for SensiumVitals, HealthPatch, EarlySense, and Masimo, respectively. For RR, these values were –0.8 (–7.4, 5.6), 0.4 (–3.9, 4.7), and 0.2 (–4.7, 4.4) respectively. HealthPatch overestimated RR, with a bias of 4.4 (limits: –4.4 to 13.3) breaths/minute. Data loss from wireless transmission varied from 13% (83 of 633 h) to 34% (122 of 360 h) for RR and 6% (47 of 727 h) to 27% (182 of 664 h) for HR.

Conclusions: All sensors were highly accurate for HR. For RR, the EarlySense, SensiumVitals sensor, and Masimo Radius-7 were reasonably accurate for RR. The accuracy for RR of the HealthPatch sensor was outside acceptable limits. Trend monitoring with wearable sensors could be valuable to timely detect patient deterioration.