a low cost rapidly scalable emergency use ventilator for the covid 19 crisis CORD-Papers-2021-10-25 (Version 1)

Title: A low-cost, rapidly scalable, emergency use ventilator for the COVID-19 crisis
Abstract: For the past 50 years, positive pressure ventilation has been a cornerstone of treatment for respiratory failure. Consensus surrounding the epidemiology of respiratory failure has permitted a relatively good fit between the supply of ventilators and the demand. However, the current COVID-19 pandemic has increased demand for mechanical ventilators well beyond supply. Respiratory failure complicates most critically ill patients with COVID-19 and is characterized by highly heterogeneous pulmonary parenchymal involvement, profound hypoxemia and pulmonary vascular injury. The profound increase in the incidence of respiratory failure has exposed critical shortages in the supply of mechanical ventilators, and those with the necessary skills to treat. While most traditional ventilators rely on an internal compressor and mixer to moderate and control the gas mixture delivered to a patient, the current emergency climate has catalyzed alternative designs that might enable greater flexibility in terms of supply chain, manufacturing, storage and maintenance. Design considerations of these 'emergency response' ventilators have generally fallen into two categories: those that rely on mechanical compression of a known volume of gas and those powered by an internal compressor to deliver time cycled pressure- or volume-limited gas to the patient. The present work introduces a low-cost, ventilator designed and built in accordance with the Emergence Use guidance provided by the US Food and Drug Administration (FDA) wherein an external gas supply feeds into the ventilator and time limited flow interruption guarantees tidal volume. The goal of this device is to allow a patient to be treated by a single ventilator platform, capable of supporting the various treatment paradigms during a potential COVID-19 related hospitalization. This is a unique aspect of this design as it attempts to become a one-device-one-visit solution to the problem. The device is designed as a single use ventilator that is sufficiently robust to treat a patient being mechanically ventilated. The overall design philosophy and its applicability in this new crisis-laden world view is first described, followed by both bench top and animal testing results used to confirm the precision, capability, safety and reliability of this low cost and novel approach to mechanical ventilation during the COVID-19 pandemic. The ventilator is shown to perform in a range of critical requirements listed in the FDA emergency regulations and can safely and effectively ventilate a porcine subject. As of August 2020, only 13 emergency ventilators have been authorized by the FDA, and this work represents the first to publish animal data using the ventilator. This proof-of-concept provides support for this cost-effective, readily mass-produced ventilator that can be used to support patients when the demand for ventilators outstrips supply in hospital settings worldwide. More details for this project can be found at https://ventilator.stanford.edu/
Published: 9/25/2020
DOI: 10.1101/2020.09.23.20199877
DOI_URL: http://doi.org/10.1101/2020.09.23.20199877
Author Name: Raymond, S J
Author link: https://covid19-data.nist.gov/pid/rest/local/author/raymond_s_j
Author Name: Wesolowski, T
Author link: https://covid19-data.nist.gov/pid/rest/local/author/wesolowski_t
Author Name: Baker, S
Author link: https://covid19-data.nist.gov/pid/rest/local/author/baker_s
Author Name: Liu, Y
Author link: https://covid19-data.nist.gov/pid/rest/local/author/liu_y
Author Name: Edmunds, J L
Author link: https://covid19-data.nist.gov/pid/rest/local/author/edmunds_j_l
Author Name: Bustamante, M J
Author link: https://covid19-data.nist.gov/pid/rest/local/author/bustamante_m_j
Author Name: Ley, B
Author link: https://covid19-data.nist.gov/pid/rest/local/author/ley_b
Author Name: Free, D
Author link: https://covid19-data.nist.gov/pid/rest/local/author/free_d
Author Name: Maharbiz, M
Author link: https://covid19-data.nist.gov/pid/rest/local/author/maharbiz_m
Author Name: Van Wert, R
Author link: https://covid19-data.nist.gov/pid/rest/local/author/van_wert_r
Author Name: Cornfield, D N
Author link: https://covid19-data.nist.gov/pid/rest/local/author/cornfield_d_n
Author Name: Camarillo, D B
Author link: https://covid19-data.nist.gov/pid/rest/local/author/camarillo_d_b
sha: 7fc33b0cde750b1e45f35b8b456418f5c0074009
license: medrxiv
source_x: MedRxiv; WHO
source_x_url: https://www.who.int/
url: http://medrxiv.org/cgi/content/short/2020.09.23.20199877v1?rss=1 https://doi.org/10.1101/2020.09.23.20199877
has_full_text: TRUE
Keywords Extracted from Text Content: patient porcine patients COVID-19 pulmonary parenchymal FDA Food pulmonary vascular one-device-one-visit caudal dorsal lung fields dorsal recumbency Figs 2 50mmHg patient line heart pCO 2 COVID-19 patients body oxygen 38.2mmHg 1-3psi nasal canula/ Food lungs mucus COVID-19 cellular people Tube wall pigs venous [3] · 52.2mmHg globe EUA blood FDA's × ventilator-induced lung cmH 2 O. humans tracheal collar Arterial ventilator-specific parts valves airways tube EUA/COVID-19 Blood FDA's EUA Figure 1 [4] emergency/rapid-response Delivered/Tidal Pressure-Limited-Time-Cycled patients 10ml/kg venous blood lines lung O2U Oxygen one-device-one-visit V T lung tissue https://doi.org/10.1101/2020.09.23.20199877 doi FiO 2 porcine medRxiv FDA Lung venous line left parts pig pressure-control medRxiv preprint Figure 9 FDA/regulatory Ambu-bag alveolar medRxiv preprint Figure 4 medRxiv preprint arterial Figures 2 to 4 62.1mmHg ChanZuckerberg BioHub
Extracted Text Content in Record: First 5000 Characters:For the past 50 years, positive pressure ventilation has been a cornerstone of treatment for respiratory failure. Consensus surrounding the epidemiology of respiratory failure has permitted a relatively good fit between the supply of ventilators and the demand. However, the current COVID-19 pandemic has increased demand for mechanical ventilators well beyond supply. Respiratory failure complicates most critically ill patients with COVID-19 and is characterized by highly heterogeneous pulmonary parenchymal involvement, profound hypoxemia and pulmonary vascular injury. The profound increase in the incidence of respiratory failure has exposed critical shortages in the supply of mechanical ventilators, and those with the necessary skills to treat. While most traditional ventilators rely on an internal compressor and mixer to moderate and control the gas mixture delivered to a patient, the current emergency climate has catalyzed alternative designs that might enable greater flexibility in terms of supply chain, manufacturing, storage and maintenance. Design considerations of these "emergency response" ventilators have generally fallen into two categories: those that rely on mechanical compression of a known volume of gas and those powered by an internal compressor to deliver time cycled pressure-or volume-limited gas to the patient. The present work introduces a low-cost, ventilator designed and built in accordance with the Emergence Use guidance provided by the US Food and Drug Administration (FDA) wherein an external gas supply feeds into the ventilator and time limited flow interruption guarantees tidal volume. The goal of this device is to allow a patient to be treated by a single ventilator platform, capable of supporting the various treatment paradigms during a potential COVID-19 related hospitalization. This is a unique aspect of this design as it attempts to become a one-device-one-visit solution to the problem. The device is designed as a single use ventilator that is sufficiently robust to treat a patient being mechanically ventilated. The overall design philosophy and its applicability in this new crisis-laden world view is first described, followed by both bench top and animal testing results used to confirm the precision, capability, safety and reliability of this low cost and novel approach to mechanical ventilation during the COVID-19 pandemic. The ventilator is shown to perform in a range of critical requirements listed in the FDA emergency regulations and can safely and effectively ventilate a porcine subject. As of August 2020, only 13 emergency ventilators have been authorized by the FDA, and this work represents the first to publish animal data using the ventilator. This proof-of-concept provides support for this cost-effective, readily mass-produced ventilator that can be used to support patients when the demand for ventilators outstrips supply in hospital settings worldwide. More details for this project can be found at COVID-19 is highly contagious and results in a wide range of respiratory distress states [1] , the World Health Organization estimates that 1 in 5 adults who contract the disease will require hospitalization for breathing difficulties, and 1 in 20 will end up in the ICU under critical care, requiring a ventilator [2] . These factors mean that, as was seen during the early stages of the 2020 pandemic, and with the virus expected to persist around the world for months/years to come [3] , hospitals are at risk of becoming overwhelmed with the need for both ventilators and operators who can manage patients suffering from the respiratory complications that COVID-19 can induce. If insufficient numbers of existing ventilators are present, and if there are not enough trained operators [4] , patients in need of adequate ventilation will be left with a lower standard of care. The worst case for this already having been experienced in northern Italy, New York City, and areas of South America where those over 60 were essentially "left to die" [5, 6] . A low-cost, rapid to manufacture ventilator, whose functionality is able to carry a patient from early admission to their final discharge from the hospital is one such solution to this problem. This device would produce the high, continuous flow of oxygen-rich air, as used in High-flow Nasal Cannula and CPAP devices. In addition, if the patient's condition worsened, the ventilator would also need to be able to ventilate in both assisted and mandatory modes, depending on the state of the patient. For rapid and high volume manufacturing, this ventilator would need to consist of a small number of parts, relative to existing options, and use very few custom parts. To address the critical shortage of mechanical ventilators (MV), the FDA provided explicit details surrounding the process and requirements for devices that might eligible for Emergency Use Authorization (EUA). This Emergency Use regulatory pathway limited requirements to those vital
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