Downey, C orcid.org/0000-0001-9818-8002, Ng, S, Jayne, D orcid.org/0000-0002-8725-3283 et al. (1 more author) (2019) Reliability of a wearable wireless patch for continuous remote monitoring of vital signs in patients recovering from major surgery: a clinical validation study from the TRaCINg trial. BMJ Open, 9. e031150. ISSN 2044-6055
Abstract
Objective: To validate whether a wearable remote vital signs monitor could accurately measure heart rate (HR), respiratory rate (RR) and temperature in a postsurgical patient population at high risk of complications.
Design: Manually recorded vital signs data were paired with vital signs data derived from the remote monitor set in patients participating in the Trial of Remote versus Continuous INtermittent monitoring (TRaCINg) study: a trial of continuous remote vital signs monitoring.
Setting: St James’s University Hospital, UK.
Participants: 51 patients who had undergone major elective general surgery.
Interventions: The intervention was the SensiumVitals monitoring system. This is a wireless patch worn on the patient’s chest that measures HR, RR and temperature continuously. The reference standard was nurse-measured manually recorded vital signs.
Primary and secondary outcome measures: The primary outcomes were the 95% limits of agreement between manually recorded and wearable patch vital sign recordings of HR, RR and temperature. The secondary outcomes were the percentage completeness of vital sign patch data for each vital sign.
Results: 1135 nurse observations were available for analysis. There was no clinically meaningful bias in HR (1.85 bpm), but precision was poor (95% limits of agreement −23.92 to 20.22 bpm). Agreement was poor for RR (bias 2.93 breaths per minute, 95% limits of agreement −8.19 to 14.05 breaths per minute) and temperature (bias 0.82°C, 95% limits of agreement −1.13°C to 2.78°C). Vital sign patch data completeness was 72.8% for temperature, 59.2% for HR and 34.1% for RR. Distributions of RR in manually recorded measurements were clinically implausible.
Conclusions: The continuous monitoring system did not reliably provide HR consistent with nurse measurements. The accuracy of RR and temperature was outside of acceptable limits. Limitations of the system could potentially be overcome through better signal processing. While acknowledging the time pressures placed on nursing staff, inaccuracies in the manually recorded data present an opportunity to increase awareness about the importance of manual observations, particularly with regard to methods of manual HR and RR measurements.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Inst of Biomed & Clin Sciences (LIBACS) (Leeds) > Trans Anaesthetics & Surgical Sciences (Leeds) |
Funding Information: | Funder Grant number NIHR National Inst Health Research drf-2016-09-037 |
Depositing User: | Symplectic Publications |
Date Deposited: | 29 Jul 2019 13:44 |
Last Modified: | 25 Jun 2023 21:55 |
Status: | Published |
Publisher: | BMJ Publishing Group |
Identification Number: | 10.1136/bmjopen-2019-031150 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:149082 |