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Protocol
Protocol for a prospective, controlled, cross-sectional, diagnostic accuracy study to evaluate the specificity and sensitivity of ambulatory monitoring systems in the prompt detection of hypoxia and during movement
  1. Carlos Areia1,
  2. Sarah Vollam1,
  3. Philippa Piper2,
  4. Elizabeth King2,
  5. Jody Ede1,
  6. Louise Young1,
  7. Mauro Santos3,
  8. Marco A F Pimentel3,
  9. Cristian Roman3,
  10. Mirae Harford1,
  11. Akshay Shah4,
  12. Owen Gustafson2,
  13. Matthew Rowland1,
  14. Lionel Tarassenko3,
  15. Peter J Watkinson1
  1. 1 Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, Oxfordshire, UK
  2. 2 Adult Intensive Care Unit, Oxford University Hospitals NHS Foundation Trust, Oxford, Oxfordshire, UK
  3. 3 Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, Oxfordshire, UK
  4. 4 Radcliffe Department of Medicine, University of Oxford, Oxford, Oxfordshire, UK
  1. Correspondence to Mr Carlos Areia; carlos.morgadoareia{at}ndcn.ox.ac.uk

Abstract

Introduction Automated continuous ambulatory monitoring may provide an alternative to intermittent manual vital signs monitoring. This has the potential to improve frequency of measurements, timely escalation of care and patient safety. However, a major barrier to the implementation of these wearable devices in the ward environment is their uncertain reliability, efficiency and data fidelity. The purpose of this study is to test performance of selected devices in a simulated clinical setting including during movement and low levels of peripheral oxygen saturation.

Methods and analysis This is a single centre, prospective, controlled, cross-sectional, diagnostic accuracy study to determine the specificity and sensitivity of currently available ambulatory vital signs monitoring equipment in the detection of hypoxia and the effect of movement on data acquisition. We will recruit up to 45 healthy volunteers who will attend a single study visit; starting with a movement phase and followed by the hypoxia exposure phase where we will gradually decrease saturation levels down to 80%. We will simultaneously test one chest patch, one wrist worn only and three wrist worn with finger probe devices against ‘clinical standard ‘and ‘gold standard’ references. We will measure peripheral oxygen saturations, pulse rate, heart rate and respiratory rate continuously and arterial blood gases intermittently throughout the study.

Ethics and dissemination This study has received ethical approval by the East of Scotland Research Ethics Service REC 2 (19/ES/0008). The results will be broadly distributed through conference presentations and peer-reviewed publications.

Trial registration number ISRCTN61535692 registered on 10/06/2019.

  • hypoxia
  • ambulatory monitoring
  • vital signs
  • wearable devices
https://creativecommons.org/licenses/by/4.0/

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/.

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Footnotes

  • Twitter @C_Areia, @MiraeHarford

  • Contributors Authorship is determined in accordance with the ICMJE guidelines: CA, SV, PP, LT and PW drafted the initial protocol. CA, SV, EK, JE, LY, OG, CR, MR, MP and MS will conduct the study procedures and data acquisition. AS and MH reviewed protocol and will provide medical cover in the study days. CA drafted the manuscript and all authors reviewed and approved it.The funders have had no role in the study protocol design or the preparation of this manuscript, and will have no role in the collection, management, analysis and interpretation of the data or the writing of the final report.

  • Funding This study/project is funded by the NIHR Biomedical Research Centre, Oxford. PW and LT are supported by the NIHR Biomedical Research Centre, Oxford.

  • Competing interests PW and LT report significant grants from the National Institute of Health Research (NIHR), UK and the NIHR Biomedical Research Centre, Oxford, during the conduct of the study. PW and LT report modest grants and personal fees from Sensyne Health, outside the submitted work. PW and LT work part-time for Sensyne Health and hold shares in the company.

  • Patient consent for publication Not required.

  • Ethics approval This study has received ethical approval by the East of Scotland Research Ethics Service REC 2 (19/ES/0008).

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

  • Data availability statement Data are available upon reasonable request. Deidentified participant data may be available in the end of the study upon reasonable requests.

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