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Protocol of a pilot-scale, single-arm, observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients

BACKGROUND: Fluid overload has a high prevalence in haemodialysis patients and is an important risk factor for excess mortality and hospitalisations. Despite the risks associated with chronic fluid overload, it is clinically difficult to assess and maintain fluid status adequately. Current methods o...

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Autores principales: Sandys, Vicki, Edwards, Colin, McAleese, Paul, O’Hare, Emer, O’Seaghdha, Conall
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8785447/
https://www.ncbi.nlm.nih.gov/pubmed/35073985
http://dx.doi.org/10.1186/s40814-022-00976-7
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author Sandys, Vicki
Edwards, Colin
McAleese, Paul
O’Hare, Emer
O’Seaghdha, Conall
author_facet Sandys, Vicki
Edwards, Colin
McAleese, Paul
O’Hare, Emer
O’Seaghdha, Conall
author_sort Sandys, Vicki
collection PubMed
description BACKGROUND: Fluid overload has a high prevalence in haemodialysis patients and is an important risk factor for excess mortality and hospitalisations. Despite the risks associated with chronic fluid overload, it is clinically difficult to assess and maintain fluid status adequately. Current methods of fluid status assessment are either imprecise or time intensive. In particular, to date, no method exists to accurately assess fluid status during the interdialytic interval. OBJECTIVES: This pilot study aimed to evaluate whether a prototype wearable hydration monitor can accurately and reproducibly detect fluid overload in the haemodialysis population when compared to haemodialysis and bioimpedance data. METHODS: A prospective, open-label, single-arm observational trial of 20 patients commenced in January 2021 in a single haemodialysis centre in Ireland, with a wearable hydration monitor, the Sixty device. The Sixty device uses diffuse reflectance spectroscopy to measure fluid levels at the level of the subdermis and uses machine learning to develop an algorithm that can determine fluid status. The Sixty device was worn at every dialysis session and nocturnally over a three-week observational period. Haemodialysis parameters including interdialytic weight gain, ultrafiltration volume, blood pressure, and relative blood volume were collected from each session, and bioimpedance measurements using the Fresenius body composition monitor were performed on 4 occasions as a comparator. The primary objective of this trial was to determine the accuracy and reproducibility of the Sixty device compared to bioimpedance measurements. CONCLUSION: If the accuracy of the wearable hydration monitor is validated, further studies will be conducted to integrate the device output into a multi-parameter machine learning algorithm that can provide patients with actionable insights to manage fluid overload in the interdialytic period. TRIAL REGISTRATION: www.clinicaltrials.govNCT04623281. Registered November 10th, 2020.
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spelling pubmed-87854472022-01-24 Protocol of a pilot-scale, single-arm, observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients Sandys, Vicki Edwards, Colin McAleese, Paul O’Hare, Emer O’Seaghdha, Conall Pilot Feasibility Stud Study Protocol BACKGROUND: Fluid overload has a high prevalence in haemodialysis patients and is an important risk factor for excess mortality and hospitalisations. Despite the risks associated with chronic fluid overload, it is clinically difficult to assess and maintain fluid status adequately. Current methods of fluid status assessment are either imprecise or time intensive. In particular, to date, no method exists to accurately assess fluid status during the interdialytic interval. OBJECTIVES: This pilot study aimed to evaluate whether a prototype wearable hydration monitor can accurately and reproducibly detect fluid overload in the haemodialysis population when compared to haemodialysis and bioimpedance data. METHODS: A prospective, open-label, single-arm observational trial of 20 patients commenced in January 2021 in a single haemodialysis centre in Ireland, with a wearable hydration monitor, the Sixty device. The Sixty device uses diffuse reflectance spectroscopy to measure fluid levels at the level of the subdermis and uses machine learning to develop an algorithm that can determine fluid status. The Sixty device was worn at every dialysis session and nocturnally over a three-week observational period. Haemodialysis parameters including interdialytic weight gain, ultrafiltration volume, blood pressure, and relative blood volume were collected from each session, and bioimpedance measurements using the Fresenius body composition monitor were performed on 4 occasions as a comparator. The primary objective of this trial was to determine the accuracy and reproducibility of the Sixty device compared to bioimpedance measurements. CONCLUSION: If the accuracy of the wearable hydration monitor is validated, further studies will be conducted to integrate the device output into a multi-parameter machine learning algorithm that can provide patients with actionable insights to manage fluid overload in the interdialytic period. TRIAL REGISTRATION: www.clinicaltrials.govNCT04623281. Registered November 10th, 2020. BioMed Central 2022-01-24 /pmc/articles/PMC8785447/ /pubmed/35073985 http://dx.doi.org/10.1186/s40814-022-00976-7 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Sandys, Vicki
Edwards, Colin
McAleese, Paul
O’Hare, Emer
O’Seaghdha, Conall
Protocol of a pilot-scale, single-arm, observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients
title Protocol of a pilot-scale, single-arm, observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients
title_full Protocol of a pilot-scale, single-arm, observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients
title_fullStr Protocol of a pilot-scale, single-arm, observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients
title_full_unstemmed Protocol of a pilot-scale, single-arm, observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients
title_short Protocol of a pilot-scale, single-arm, observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients
title_sort protocol of a pilot-scale, single-arm, observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8785447/
https://www.ncbi.nlm.nih.gov/pubmed/35073985
http://dx.doi.org/10.1186/s40814-022-00976-7
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