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.
Subject(s)
COVID-19 , Noninvasive Ventilation , Respiratory Distress Syndrome , Sheep , Animals , COVID-19/therapy , Ventilators, Mechanical , Tidal Volume , Respiratory Distress Syndrome/therapy , SARS-CoV-2ABSTRACT
The COVID-19 pandemic has revealed a ventilator deficit in the global health system for this scenario. For this reason, several national and international projects have been developed to get done prototypes of ventilators which could be easy and fast to manufacture. One of the requirements of the AEMPS for conducting clinical studies with new prototypes is through the validation of these new prototypes in an animal model. Therefore, it is important to achieve an animal model which allows us to easily reproduce different clinical scenarios. In this article, we describe the use of a sheep as a research model to assess a prototype ventilator. The animal was anesthetized for 10â¯h in which the prototype was tested in up to 6 different scenarios. This model is effective and easy to reproduce, making it an excellent choice for this kind of research.
Subject(s)
COVID-19 , Respiratory Distress Syndrome , Animals , Humans , Pandemics , SARS-CoV-2 , Sheep , Ventilators, MechanicalABSTRACT
The COVID-19 pandemic has revealed a ventilator deficit in the global health system for this scenario. For this reason, several national and international projects have been developed to get done prototypes of ventilators which could be easy and fast to manufacture. One of the requirements of the AEMPS for conducting clinical studies with new prototypes is through the validation of these new prototypes in an animal model. Therefore, it is important to achieve an animal model which allows us to easily reproduce different clinical scenarios. In this article, we describe the use of a sheep as a research model to assess a prototype ventilator. The animal was anesthetized for 10hours in which the prototype was tested in up to 6different scenarios. This model is effective and easy to reproduce, making it an excellent choice for this kind of research.