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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
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 wearab...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7044954/ https://www.ncbi.nlm.nih.gov/pubmed/31932393 http://dx.doi.org/10.1136/bmjopen-2019-034404 |
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author | Areia, Carlos Vollam, Sarah Piper, Philippa King, Elizabeth Ede, Jody Young, Louise Santos, Mauro Pimentel, Marco A F Roman, Cristian Harford, Mirae Shah, Akshay Gustafson, Owen Rowland, Matthew Tarassenko, Lionel Watkinson, Peter J |
author_facet | Areia, Carlos Vollam, Sarah Piper, Philippa King, Elizabeth Ede, Jody Young, Louise Santos, Mauro Pimentel, Marco A F Roman, Cristian Harford, Mirae Shah, Akshay Gustafson, Owen Rowland, Matthew Tarassenko, Lionel Watkinson, Peter J |
author_sort | Areia, Carlos |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7044954 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-70449542020-03-09 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 Areia, Carlos Vollam, Sarah Piper, Philippa King, Elizabeth Ede, Jody Young, Louise Santos, Mauro Pimentel, Marco A F Roman, Cristian Harford, Mirae Shah, Akshay Gustafson, Owen Rowland, Matthew Tarassenko, Lionel Watkinson, Peter J BMJ Open Diagnostics 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. BMJ Publishing Group 2020-01-12 /pmc/articles/PMC7044954/ /pubmed/31932393 http://dx.doi.org/10.1136/bmjopen-2019-034404 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. 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/. |
spellingShingle | Diagnostics Areia, Carlos Vollam, Sarah Piper, Philippa King, Elizabeth Ede, Jody Young, Louise Santos, Mauro Pimentel, Marco A F Roman, Cristian Harford, Mirae Shah, Akshay Gustafson, Owen Rowland, Matthew Tarassenko, Lionel Watkinson, Peter J 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Diagnostics |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7044954/ https://www.ncbi.nlm.nih.gov/pubmed/31932393 http://dx.doi.org/10.1136/bmjopen-2019-034404 |
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