Cargando…
Implementation of a Comprehensive Testing Protocol for a Rapidly Manufactured Mechanical Ventilator
INTRODUCTION: The COVID-19 pandemic highlighted that surges in critical care demand can overwhelm existing healthcare infrastructures, most evident in the acute shortage of mechanical ventilators across the globe. Despite efforts to encourage urgent authorization of newly developed emergency ventila...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9212985/ https://www.ncbi.nlm.nih.gov/pubmed/37496578 http://dx.doi.org/10.1016/j.opresp.2022.100189 |
_version_ | 1784730736986685440 |
---|---|
author | Baglyas, Szabolcs Valko, Luca Gyarmathy, V. Anna LaPradd, Michelle Gal, Janos Lorx, Andras |
author_facet | Baglyas, Szabolcs Valko, Luca Gyarmathy, V. Anna LaPradd, Michelle Gal, Janos Lorx, Andras |
author_sort | Baglyas, Szabolcs |
collection | PubMed |
description | INTRODUCTION: The COVID-19 pandemic highlighted that surges in critical care demand can overwhelm existing healthcare infrastructures, most evident in the acute shortage of mechanical ventilators across the globe. Despite efforts to encourage urgent authorization of newly developed emergency ventilators, the currently available testing protocols are not internationally accepted, standardized and none address testing in clinical settings. The aim of this study was to compile and perform a comprehensive clinical testing protocol for a newly developed emergency ventilator. METHODS: Using previously available guidance, we compiled a sequential testing protocol with a: 1. preclinical, 2. safety testing, 3. clinician usability test and 4. clinical stage involving respiratory failure patients. The protocol was then tested on the Luca ventilator, a mechanical ventilator capable of sophisticated ventilator settings rapidly developed specifically in response to the COVID-19 pandemic. RESULTS: During the pre-clinical/safety stages, the ventilator produced pressure and volume changes deemed acceptable by the Rapidly Manufactured Ventilator System guideline. Furthermore, our protocol allowed the identification of a number of issues that were easily resolved with minor software adjustments. Usability was excellent (overall System Usability Scale score = 90.5). Clinical testing revealed that a sampling frame of 15 critically ill patients was sufficiently powered to detect any significant, clinically relevant differences between the Luca ventilator and a standard ICU ventilator. CONCLUSIONS: The ventilator was accurate, reliable, safe, and user-friendly. The implementation of a comprehensive, standardized pre-clinical/clinical testing protocol is feasible, potentially enabling the safe and timely emergency authorization of rapidly developed mechanical ventilators crucial in pandemic situations. |
format | Online Article Text |
id | pubmed-9212985 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-92129852022-06-22 Implementation of a Comprehensive Testing Protocol for a Rapidly Manufactured Mechanical Ventilator Baglyas, Szabolcs Valko, Luca Gyarmathy, V. Anna LaPradd, Michelle Gal, Janos Lorx, Andras Open Respir Arch Original Article INTRODUCTION: The COVID-19 pandemic highlighted that surges in critical care demand can overwhelm existing healthcare infrastructures, most evident in the acute shortage of mechanical ventilators across the globe. Despite efforts to encourage urgent authorization of newly developed emergency ventilators, the currently available testing protocols are not internationally accepted, standardized and none address testing in clinical settings. The aim of this study was to compile and perform a comprehensive clinical testing protocol for a newly developed emergency ventilator. METHODS: Using previously available guidance, we compiled a sequential testing protocol with a: 1. preclinical, 2. safety testing, 3. clinician usability test and 4. clinical stage involving respiratory failure patients. The protocol was then tested on the Luca ventilator, a mechanical ventilator capable of sophisticated ventilator settings rapidly developed specifically in response to the COVID-19 pandemic. RESULTS: During the pre-clinical/safety stages, the ventilator produced pressure and volume changes deemed acceptable by the Rapidly Manufactured Ventilator System guideline. Furthermore, our protocol allowed the identification of a number of issues that were easily resolved with minor software adjustments. Usability was excellent (overall System Usability Scale score = 90.5). Clinical testing revealed that a sampling frame of 15 critically ill patients was sufficiently powered to detect any significant, clinically relevant differences between the Luca ventilator and a standard ICU ventilator. CONCLUSIONS: The ventilator was accurate, reliable, safe, and user-friendly. The implementation of a comprehensive, standardized pre-clinical/clinical testing protocol is feasible, potentially enabling the safe and timely emergency authorization of rapidly developed mechanical ventilators crucial in pandemic situations. Elsevier 2022-06-15 /pmc/articles/PMC9212985/ /pubmed/37496578 http://dx.doi.org/10.1016/j.opresp.2022.100189 Text en © 2022 Sociedad Española de Neumología y Cirugía Torácica (SEPAR). Published by Elsevier España, S.L.U. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Original Article Baglyas, Szabolcs Valko, Luca Gyarmathy, V. Anna LaPradd, Michelle Gal, Janos Lorx, Andras Implementation of a Comprehensive Testing Protocol for a Rapidly Manufactured Mechanical Ventilator |
title | Implementation of a Comprehensive Testing Protocol for a Rapidly Manufactured Mechanical Ventilator |
title_full | Implementation of a Comprehensive Testing Protocol for a Rapidly Manufactured Mechanical Ventilator |
title_fullStr | Implementation of a Comprehensive Testing Protocol for a Rapidly Manufactured Mechanical Ventilator |
title_full_unstemmed | Implementation of a Comprehensive Testing Protocol for a Rapidly Manufactured Mechanical Ventilator |
title_short | Implementation of a Comprehensive Testing Protocol for a Rapidly Manufactured Mechanical Ventilator |
title_sort | implementation of a comprehensive testing protocol for a rapidly manufactured mechanical ventilator |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9212985/ https://www.ncbi.nlm.nih.gov/pubmed/37496578 http://dx.doi.org/10.1016/j.opresp.2022.100189 |
work_keys_str_mv | AT baglyasszabolcs implementationofacomprehensivetestingprotocolforarapidlymanufacturedmechanicalventilator AT valkoluca implementationofacomprehensivetestingprotocolforarapidlymanufacturedmechanicalventilator AT gyarmathyvanna implementationofacomprehensivetestingprotocolforarapidlymanufacturedmechanicalventilator AT lapraddmichelle implementationofacomprehensivetestingprotocolforarapidlymanufacturedmechanicalventilator AT galjanos implementationofacomprehensivetestingprotocolforarapidlymanufacturedmechanicalventilator AT lorxandras implementationofacomprehensivetestingprotocolforarapidlymanufacturedmechanicalventilator |