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Health informatics
Protocol
ChroniSense National Early Warning Score Study (CHESS): a wearable wrist device to measure vital signs in hospitalised patients—protocol and study design
  1. Michelle Helena Van Velthoven1,
  2. Felicia Adjei2,
  3. Dimitris Vavoulis3,
  4. Glenn Wells4,
  5. David Brindley1,5,
  6. Attila Kardos2,6
  1. 1 Department of Paediatrics, University of Oxford, Oxford, UK
  2. 2 Department of Cardiology, Milton Keynes University Hospital NHS Foundation Trust, Milton Keynes, UK
  3. 3 Department of Oncology, University of Oxford, Oxford, UK
  4. 4 Oxford Academic Health Science Centre, Oxford, UK
  5. 5 Said Buisness School, University of Oxford, Oxford, Oxfordshire, UK
  6. 6 Faculty of Life Sciences, University of Buckingham, Buckingham, United Kingdom
  1. Correspondence to Dr Michelle Helena Van Velthoven; michelle.vanvelthoven{at}paediatrics.ox.ac.uk; Professor Attila Kardos; attila.kardos{at}cardiov.ox.ac.uk

Abstract

Introduction The National Early Warning Score is used as standard clinical practice in the UK as a track and trigger system to monitor hospitalised patients. Currently, nurses are tasked to take routine vital signs measurements and manually record these on a clinical chart. Wearable devices could provide an easier, reliable, more convenient and cost-effective method of monitoring. Our aim is to evaluate the clinical validity of Polso (ChroniSense Medical, Yokneam Illit, Israel), a wrist-based device, to provide National Early Warning Scores.

Methods and analysis We will compare Polso National Early Warning Score measurements to the currently used manual measurements in a UK Teaching District General Hospital. Patients aged 18 years or above who require recordings of observations of vital signs at least every 6 hours will be enrolled after consenting. The sample size for the study was calculated to be 300 participants based on the assumption that the final dataset will include four pairs of measurements per-patient and per-vital sign, resulting in a total of 1200 pairs of data points per vital sign. The primary outcome is the agreement on the individual parameter scores and values of the National Early Warning Score: (1) respiratory rate, (2) oxygen saturation, (3) body temperature, (4) systolic blood pressure and (5) heart rate. Secondary outcomes are the agreement on the aggregate National Early Warning Score. The incidence of adverse events will be recorded. The measurements by the device will not be used for the clinical decision-making in this study.

Ethics and dissemination We obtained ethical approval, reference number 18/LO/0123 from London—Hampstead Research Ethics Committee, through the Integrated Research Application System, (reference number: 235 034. The study received no objection from the Medicine and Health Regulatory Authority, reference number: CI/20018/005 and has National Institute for Health Research portfolio adoption status CPMS number: 32 532.

Trial registration number NCT03448861; Pre-results.

  • health apps
  • Mobile Applications [MeSH]
  • digital health
  • early warning signs
  • medical device

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-028219

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    Footnotes

    • MHVV and FA are joint first authors.

    • GW, DB and AK are joint senior authors.

    • Contributors MHVV wrote the protocol, FA revised the protocol, DV conducted the power calculation, GW and DB commented on the protocol. The concept of the study was conceived as well as the protocol revised and corrected by AK.

    • Funding This study was supported by the SENS Research Foundation with a donation from ChroniSense Medical.

    • Disclaimer The funder did not influence the study design; and will not influence data collection, management, analysis and interpretation of data; writing of the report; and the decision to submit the report for publication.

    • Competing interests The research sponsor for this study is Milton Keynes University Hospital (MKUH) NHS Foundation Trust and collaborator is Oxford University NHS Foundation Trust. DB is a stockholder in Translation Ventures. (Charlbury, Oxfordshire, UK) and IP Asset Ventures (Oxford, Oxfordshire, UK), companies that, among other services, provide cell therapy biomanufacturing, regulatory and financial advice to pharmaceutical clients. DB is also subject to the CFA Institute’s codes, standards and guidelines, so, he must stress that this piece is provided for academic interest only and must not be construed in any way as an investment recommendation. Additionally, at the time of publication, DB and the organisations with which he is affiliated may or may not have agreed and/or have pending funding commitments from the organisations named here.

    • Patient consent for publication Not required.

    • Ethics approval We obtained ethics approval through the Integrated Research Application System (IRAS) for the CHESS: ChroniSense National Early Warning Score Study, reference number: 18/LO/0123.

    • Provenance and peer review Not commissioned; externally peer reviewed.