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MADVent: A low-cost ventilator for patients with COVID-19.

ABSTRACT: The COVID-19 pandemic has produced critical shortages of ventilators worldwide. There is an unmet need for rapidly deployable, emergency-use ventilators with sufficient functionality to manage COVID-19 patients with severe acute respiratory distress syndrome. Here, we show the development and validation of a simple, portable and low-cost ventilator that may be rapidly manufactured with minimal susceptibility to supply chain disruptions. This single-mode continuous, mandatory, closed-loop, pressure-controlled, time-terminated emergency ventilator offers robust safety and functionality absent in existing solutions to the ventilator shortage. Validated using certified test lungs over a wide range of compliances, pressures, volumes and resistances to meet U.S. Food and Drug Administration standards of safety and efficacy, an Emergency Use Authorization is in review for this system. This emergency ventilator could eliminate controversial ventilator rationing or splitting to serve multiple patients. All design and validation information is provided to facilitate ventilator production even in resource-limited settings.

SUBMITTER: Vasan A

PROVIDER: S-EPMC7300530 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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MADVent: A low-cost ventilator for patients with COVID-19.

Vasan Aditya A Weekes Reiley R Connacher William W Sieker Jeremy J Stambaugh Mark M Suresh Preetham P Lee Daniel E DE Mazzei William W Schlaepfer Eric E Vallejos Theodore T Petersen Johan J Merritt Sidney S Petersen Lonnie L Friend James J

Medical devices & sensors 20200627 4

The COVID-19 pandemic has produced critical shortages of ventilators worldwide. There is an unmet need for rapidly deployable, emergency-use ventilators with sufficient functionality to manage COVID-19 patients with severe acute respiratory distress syndrome. Here, we show the development and validation of a simple, portable and low-cost ventilator that may be rapidly manufactured with minimal susceptibility to supply chain disruptions. This single-mode continuous, mandatory, closed-loop, pressu ...[more]

PMID: 32838208

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Project description:The ongoing severe acute respiratory syndrome coronavirus 2 or coronavirus disease 2019 pandemic has demonstrated the potential need for a low-cost, rapidly deployable ventilator. Based on this premise, we sought to design a ventilator with the following criteria: 1) standard components that are accessible to the public, 2) "open-source" compatibility to allow anyone to easily recreate the system, 3) ability to ventilate in acute respiratory distress syndrome, and 4) lowest possible cost to provide adequate oxygenation and ventilation.DesignWe pursued development of a pneumatic-type ventilator. The basic design involves three electrically controlled solenoid valves, a pressure chamber, the patient breathing circuit, a positive end-expiratory pressure valve, and an electronics control system. Multiple safety elements were built into the design. The user-friendly interface allows simple control of ventilator settings. The ventilator delivers a hybrid form of pneumatic, assist-control ventilation, with predicted tidal volumes of 300-800 mL, positive end-expiratory pressure 0-20 cm H2O, and Fio2 21-100%.Main resultsThe ventilator was extensively tested with two separate high-fidelity lung simulators and a porcine in vivo model. Both lung simulators were able to simulate a variety of pathologic states, including obstructive lung disease and acute respiratory distress syndrome. The ventilator performed well across all simulated scenarios. Similarly, a porcine in vivo model was used to assess performance in live tissue, with a specific emphasis on gas exchange. The ventilator performed well in vivo and demonstrated noninferior ventilation and oxygenation when compared with the standard ventilator.ConclusionsThe Portsmouth Ventilator was able to perform well across all simulated pathologies and in vivo. All components may be acquired by the public for a cost of approximately $250 U.S.D. Although this ventilator has limited functionality compared with modern ventilators, the simple design appears to be safe and would allow for rapid mass production if ventilator surge demand exceeded supply.

Project description:ObjectivesVentilator-associated lower respiratory tract infections (VA-LRTIs) are associated with prolonged length of stay and increased mortality. We aimed to investigate the occurrence of bacterial VA-LRTI among mechanically ventilated COVID-19 patients and compare these findings to non-COVID-19 cohorts throughout the first and second wave of the pandemic.DesignRetrospective cohort study.SettingKarolinska University Hospital, Stockholm, Sweden.PatientsAll patients greater than or equal to 18 years treated with mechanical ventilation between January 1, 2011, and December 31, 2020.InterventionsNone.Measurements and main resultsThe cohort consisted of 20,223 ICU episodes (479 COVID-19), with a VA-LRTI incidence proportion of 30% (129/426) in COVID-19 and 18% (1,081/5,907) in non-COVID-19 among patients ventilated greater than or equal to 48 hours. The median length of ventilator treatment for COVID-19 patients was 10 days (interquartile range, 5-18 d), which was significantly longer than for all other investigated specific diagnoses. The VA-LRTI incidence rate per 1,000 ventilator days at risk was 31 (95% CI, 26-37) for COVID-19 and 34 (95% CI, 32-36) for non-COVID-19. With COVID-19 as reference, adjusted subdistribution hazard ratios for VA-LRTI was 0.29-0.50 (95% CI, < 1) for influenza, bacterial pneumonia, acute respiratory distress syndrome, and severe sepsis, but 1.38 (95% CI, 1.15-1.65) for specific noninfectious diagnoses. Compared with COVID-19 in the first wave of the pandemic, COVID-19 in the second wave had adjusted subdistribution hazard ratio of 1.85 (95% CI, 1.14-2.99). In early VA-LRTI Staphylococcus aureus was more common and Streptococcus pneumoniae, Haemophilus influenzae, and Escherichia coli less common in COVID-19 patients, while Serratia species was more often identified in late VA-LRTI.ConclusionsCOVID-19 is associated with exceptionally long durations of mechanical ventilation treatment and high VA-LRTI occurrence proportions. The incidence rate of VA-LRTI was compared with the pooled non-COVID-19 cohort, however, not increased in COVID-19. Significant differences in the incidence of VA-LRTI occurred between the first and second wave of the COVID-19 pandemic.

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MADVent: A low-cost ventilator for patients with COVID-19.

Publications

MADVent: A low-cost ventilator for patients with COVID-19.

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