Pre-clinical validation of a turbine-based ventilator for invasive ventilation-The ACUTE-19 ventilator.

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Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Casañ-Pallardó M
  • Redondo-García JI
  • Viscasillas-Monteagudo J
  • Gutierrez-Bautista A
  • Ramirez-Faz J
  • Alonso-Pérez P
  • Díaz-Lobato S
  • Neto AS
  • Gama de Abreu M
  • Pelosi P
  • Schultz MJ
  • open source smart breathing system ACUTE-19 investigators

Grupos

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 (V<sub>T</sub>) 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 V<sub>T</sub> in the simulated models were marginally different (largest difference 33ml [95%-confidence interval (CI) 31-36]; P&lt;.001ml). Plateau pressure (P<sub>plat</sub>) was not different (-0.3cmH<sub>2</sub>O [95%-CI -0.9 to 0.3]; P=.409), and positive end-expiratory pressure (PEEP) was marginally different (0.3 cmH<sub>2</sub>O [95%-CI 0.2 to 0.3]; P&lt;.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 P<sub>plat</sub> of 15 and 30cmH<sub>2</sub>O, 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.

Copyright © 2021 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.

Datos de la publicación

ISSN/ISSNe:
2341-1929, 2341-1929

Revista Espanola De Anestesiologia Y Reanimacion  

Tipo:
Article
Páginas:
544-555
PubMed:
36244956

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Keywords

  • Aumento de la capacidad médica; Bench study; COVID-19; Estudio de banco; Mechanical ventilation; Medical capacity surge; Rendimiento del ventilador; SARS-CoV-2; Ventilación mecánica; Ventilator performance

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