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Inicio Revista Española de Anestesiología y Reanimación (English Edition) Pre-clinical validation of a turbine-based ventilator for invasive ventilation...
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Vol. 69. Issue 9.
Pages 544-555 (November 2022)
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Vol. 69. Issue 9.
Pages 544-555 (November 2022)
Original article
Pre-clinical validation of a turbine-based ventilator for invasive ventilation—The ACUTE-19 ventilator
Validación preclínica de un respirador de turbina para la ventilación invasiva: el respirador ACUTE-19
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J.M. Alonso-Iñigoa,
Corresponding author
jmalonso@me.com

Corresponding author.
, G. Mazzinarib, M. Casañ-Pallardób, J.I. Redondo-Garcíac, J. Viscasillas-Monteagudoc, A. Gutierrez-Bautistac, J. Ramirez-Fazd, P. Alonso-Péreze, S. Díaz-Lobatof, A.S. Netog,h,i, O. Diaz-Cambroneroa, P. Argente-Navarroa, M. Gama de Abreuj,k, P. Pelosil,m, M.J. Schultzi,n,o, for the open source smart breathing system ACUTE-19 investigators
a Research Group in Perioperative Medicine, Department of Anesthesia, Critical Care and Pain Medicine, Hospital Universitario y Politécnico la Fe, Valencia, Spain
b Department of Anesthesia, Critical Care and Pain Medicine, Hospital General Universitario de Castellón, Castellón de la Plana, Castellón, Spain
c Department of Veterinary Anesthesia, Hospital Clínico Veterinario CEU, Universidad CEU Cardenal Herrera, Alfara del Patriarca, Valencia, Spain
d Department of Electrical Engineering, Universidad de Córdoba, Córdoba, Spain
e Department of Research and Innovation, Tecnikoa and C&T Fabrication S. L., Alicante, Spain
f Medical Division, Nippon Gases HealthCare & Oximesa NG, Madrid, Spain
g Department of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brasil
h Cardio-Pulmonary Department, Pulmonary Division, Instituto do Coração, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brasil
i Department of Intensive Care & Laboratory of Experimental Intensive Care and Anesthesiology (LEICA), Academic Medical Center, Amsterdam, The Netherlands
j Pulmonary Engineering Group, Department of Anesthesiology and Intensive Care Therapy, Technische Universität Dresden, Dresden, Germany
k Outcome Research Consortiu, Cleveland Clinic, Cleveland, OH, USA
l Policlinico San Martino Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy
m Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy
n Mahidol-Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand
o Nuffield Department of Medicine, University of Oxford, Oxford, UK
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Abstract
Background

The Severe Acute Respiratory Syndrome (SARS)–Coronavirus 2 (CoV–2) pandemic pressure on healthcare systems can exhaust ventilator resources, especially where resources are restricted. Our objective was a rapid preclinical evaluation of a newly developed turbine–based ventilator, named the ACUTE–19, for invasive ventilation.

Methods

Validation consisted of (a) testing tidal volume (VT) delivery in 11 simulated models, with various resistances and compliances; (b) comparison with a commercial ventilator (VIVO–50) adapting the United Kingdom Medicines and Healthcare products Regulatory Agency–recommendations for rapidly manufactured ventilators; and (c) in vivo testing in a sheep before and after inducing acute respiratory distress syndrome (ARDS) by saline lavage.

Results

Differences in VT in the simulated models were marginally different (largest difference 33ml [95%–confidence interval (CI) 31–36]; P<.001ml). Plateau pressure (Pplat) was not different (–0.3cmH2O [95%–CI –0.9 to 0.3]; P=.409), and positive end-expiratory pressure (PEEP) was marginally different (0.3 cmH2O [95%–CI 0.2 to 0.3]; P<.001) between the ACUTE–19 and the commercial ventilator. Bland–Altman analyses showed good agreement (mean bias, –0.29, [limits of agreement, 0.82 to –1.42], and mean bias 0.56 [limits of agreement, 1.94 to –0.81], at a Pplat of 15 and 30cmH2O, respectively). The ACUTE–19 achieved optimal oxygenation and ventilation before and after ARDS induction.

Conclusions

The ACUTE–19 performed accurately in simulated and animal models yielding a comparable performance with a VIVO-50 commercial device. The acute 19 can provide the basis for the development of a future affordable commercial ventilator.

Keywords:
SARS-CoV-2
COVID-19
Mechanical ventilation
Bench study
Ventilator performance
Medical capacity surge
Resumen
Antecedentes

La pandemia producida por el Síndrome Respiratorio Agudo Severo (SARS) por Coronavirus 2 (CoV-2) puede agotar los recursos sanitarios, especialmente de respiradores, en situaciones de escasez de recursos sanitarios. Nuestro objetivo fue realizar una evaluación preclínica rápida de un prototipo de respirador de turbina para la ventilación invasiva denominado ACUTE-19.

Métodos

La validación consistió en (a) evaluación de la administración de un volumen corriente (VT) en 11 modelos pulmonares simulados, con diversas resistencias y compliancias; (b) comparación con un ventilador comercial (VIVO-50) adaptando las recomendaciones de la Agencia Reguladora de Medicamentos y Productos Sanitarios del Reino Unido para ventiladores de fabricación rápida; y (c) realización pruebas in vivo en una oveja antes y después de inducir el síndrome de distrés respiratorio agudo (SDRA) mediante lavado salino.

Resultados

Las diferencias de VT en los modelos simulados fueron mínimamente diferentes (la mayor diferencia fue de 33ml [intervalo de confianza (IC) del 95%: 31 a 36]; P<,001ml). La presión de meseta (Pplat) no fue diferente (−0,3 cmH2O [IC del 95%: −0,9 a 0,3]; P=,409), y la presión positiva al final de la espiración (PEEP) fue levemente diferente (0,3cmH2O [IC del 95%: 0,2 a 0,3]; P<,001) comparando el ACUTE-19 y el ventilador comercial. El análisis de Bland-Altman mostró una buena concordancia (bias medio, −0,29, [límites de concordancia, 0,82 a −1,42], y bias medio 0,56 [límites de concordancia, 1,94 a −0,81], a una Pplat de 15 y 30cmH2O, respectivamente). El ACUTE-19 consiguió una oxigenación y ventilación óptimas antes y después de la inducción del SDRA en el modelo animal.

Conclusiones

El ACUTE-19 se comportó con precisión en los modelos simulados y animales, con un rendimiento comparable al del dispositivo comercial VIVO-50. El ACUTE-19 puede servir de base para el desarrollo de un futuro ventilador comercial asequible.

Palabras clave:
SARS-CoV-2
COVID-19
Ventilación mecánica
Estudio de banco
Rendimiento del ventilador
Aumento de la capacidad médica

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