Biological evaluation of a mechanical ventilator that operates by controlling an automated manual resuscitator. A descriptive study in swine

PLoS One. 2022 Mar 3;17(3):e0264774. doi: 10.1371/journal.pone.0264774. eCollection 2022.

Abstract

The Covid-19 outbreak challenged health systems around the world to design and implement cost-effective devices produced locally to meet the increased demand of mechanical ventilators worldwide. This study evaluates the physiological responses of healthy swine maintained under volume- or pressure-controlled mechanical ventilation by a mechanical ventilator implemented to bring life-support by automating a resuscitation bag and closely controlling ventilatory parameters. Physiological parameters were monitored in eight sedated animals (t0) prior to inducing deep anaesthesia, and during the next six hours of mechanical ventilation (t1-7). Hemodynamic conditions were monitored periodically using a portable gas analyser machine (i.e. BEecf, carbonate, SaO2, lactate, pH, PaO2, PaCO2) and a capnometer (i.e. ETCO2). Electrocardiogram, echocardiography and lung ultrasonography were performed to detect in vivo alterations in these vital organs and pathological findings from necropsy were reported. The mechanical ventilator properly controlled physiological levels of blood biochemistry such as oxygenation parameters (PaO2, PaCO2, SaO2, ETCO2), acid-base equilibrium (pH, carbonate, BEecf), and perfusion of tissues (lactate levels). In addition, histopathological analysis showed no evidence of acute tissue damage in lung, heart, liver, kidney, or brain. All animals were able to breathe spontaneously after undergoing mechanical ventilation. These preclinical data, supports the biological safety of the medical device to move forward to further evaluation in clinical studies.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Automation
  • Blood Gas Analysis
  • COVID-19 / complications
  • COVID-19 / pathology
  • COVID-19 / physiopathology
  • Cardiopulmonary Resuscitation / instrumentation*
  • Female
  • Hemodynamics
  • Male
  • Respiration
  • Respiration, Artificial / instrumentation*
  • SARS-CoV-2 / physiology
  • Swine
  • Ventilators, Mechanical*

Grants and funding

FLC received funding public Peruvian funding from the grant # 055-2020-FONDECYT administered by the Fondo Nacional de Desarrollo Científico, Tecnológico y de Innovación Tecnológica. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.