FDA Emergency Use Authorization-Approved Novel Coronavirus Disease 2019, Pressure-Regulated, Mechanical Ventilator Splitter That Enables Differential Compliance Multiplexing

Paulsen, Michael J.; Zhu, Yuanjia; Park, Matthew H.; Imbrie-Moore, Annabel M.; Baker, Sam W.; Edmonston, David Walter; Dawson, Tyler; Ly, Evan; Bell, Shannon Martin; Tran, Nick A; Jung, Jinsuh; Cedarleaf-Pavy, Jordan; Sridhar, K R; Venkataraman, Venkat; Woo, Youngki

doi:10.1097/mat.0000000000001756

Cited by 4 publications

(4 citation statements)

References 14 publications

(15 reference statements)

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“…Most of the studies of shared ventilation were based on laboratory experiments in which only test lungs were used 4,7,12,16,36 . Only a few animal experiments 5,[8][9][10] or preliminary tests on a few pairs of patients 35,37 were carried out. Further clinical studies focused on safety and effectiveness are necessary.…”

Section: Safety Indicationsmentioning

confidence: 99%

“…this approach has been criticized as insufficient to maintain stable ventilation for each patient in the event of changes in lung mechanics in any of the ventilated patients 7 . Following the COVID-19 outbreak, various new configurations of ventilator sharing systems have been proposed and tested [8][9][10][11][12] . These systems provide varying degrees of control over ventilatory branches, delivering airflow to the patients.…”

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confidence: 99%

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Automatic air volume control system for ventilation of two patients using a single ventilator: a large animal model study

Zieliński

Lisowska

Siewruk

et al. 2022

Sci Rep

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The COVID-19 pandemic outbreak led to a global ventilator shortage. Hence, various strategies for using a single ventilator to support multiple patients have been considered. A device called Ventil previously validated for independent lung ventilation was used in this study to evaluate its usability for shared ventilation. We performed experiments with a total number of 16 animals. Eight pairs of pigs were ventilated by a ventilator or anesthetic machine and by Ventil for up to 27 h. In one experiment, 200 ml of saline was introduced to one subject’s lungs to reduce their compliance. The experiments were analyzed in terms of arterial blood gases and respiratory parameters. In addition to the animal study, we performed a series of laboratory experiments with artificial lungs (ALs). The resistance and compliance of one AL (affected) were altered, while the tidal volume (TV) and peak pressure (Ppeak) in the second (unaffected) AL were analyzed. In addition, to assess the risk of transmission of pathogens between AL respiratory tracts, laboratory tests were performed using phantoms of virus particles. The physiological level of analyzed parameters in ventilated animals was maintained, except for CO2 tension, for which a permissive hypercapnia was indicated. Experiments did not lead to injuries in the animal’s lungs except for one subject, as indicated by CT scan analysis. In laboratory experiments, changes in TV and Ppeak in the unaffected AL were less than 11%, except for 2 cases where the TV change was 20%. No cross-contamination was found in simulations of pathogen transmission. We conclude that ventilation using Ventil can be considered safe in patients undergoing deep sedation without spontaneous breathing efforts.

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Section: Safety Indicationsmentioning

confidence: 99%

mentioning

confidence: 99%

Automatic air volume control system for ventilation of two patients using a single ventilator: a large animal model study

Zieliński

Lisowska

Siewruk

et al. 2022

Sci Rep

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“…Rudimentary ventilator splitting was trialed in some hospitals despite multiple professional medical bodies making statements against such practices due to safety concerns like air trapping and cross contamination (1,2). Following these statements, several groups developed and proposed alternative techniques of ventilator splitting and multiplexing that might improve patient safety (1,(3)(4)(5)(6)(7).…”

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confidence: 99%

Quantitative Comparison of Ventilation Parameters of Different Approaches to Ventilator Splitting and Multiplexing

Kim,

Roy,

McBeth

et al. 2024

Critical Care Explorations

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CONTEXT: Amid the COVID-19 pandemic, this study delves into ventilator shortages, exploring simple split ventilation (SSV), simple differential ventilation (SDV), and differential multiventilation (DMV). The knowledge gap centers on understanding their performance and safety implications. HYPOTHESIS: Our hypothesis posits that SSV, SDV, and DMV offer solutions to the ventilator crisis. Rigorous testing was anticipated to unveil advantages and limitations, aiding the development of effective ventilation approaches. METHODS AND MODELS: Using a specialized test bed, SSV, SDV, and DMV were compared. Simulated lungs in a controlled setting facilitated measurements with sensors. Statistical analysis honed in on parameters like peak inspiratory pressure (PIP) and positive end-expiratory pressure. RESULTS: Setting target PIP at 15 cm H2O for lung 1 and 12.5 cm H2O for lung 2, SSV revealed a PIP of 15.67 ± 0.2 cm H2O for both lungs, with tidal volume (Vt) at 152.9 ± 9 mL. In SDV, lung 1 had a PIP of 25.69 ± 0.2 cm H2O, lung 2 at 24.73 ± 0.2 cm H2O, and Vts of 464.3 ± 0.9 mL and 453.1 ± 10 mL, respectively. DMV trials showed lung 1’s PIP at 13.97 ± 0.06 cm H2O, lung 2 at 12.30 ± 0.04 cm H2O, with Vts of 125.8 ± 0.004 mL and 104.4 ± 0.003 mL, respectively. INTERPRETATION AND CONCLUSIONS: This study enriches understanding of ventilator sharing strategy, emphasizing the need for careful selection. DMV, offering individualization while maintaining circuit continuity, stands out. Findings lay the foundation for robust multiplexing strategies, enhancing ventilator management in crises.

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“…One novel approach of splitting ventilators emerged and obtained Food and Drug Administration (FDA) Emergency Use Authorization. 4 The ventilator sharing and monitoring system, which is a mechanical device that can split one ventilator among four patients with electronic monitoring. This mechanical system with electronic monitoring in technology enables titration of peak inspiratory pressure, tidal volume and positive end-expiratory pressure for up, VT, and PEEP for (up to 4) individual, simultaneously ventilated patients.…”

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confidence: 99%

Engineering Solutions to Biologic Challenges Exemplified in Times of Crisis

Whitson¹

2022

ASAIO Journal

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FDA Emergency Use Authorization-Approved Novel Coronavirus Disease 2019, Pressure-Regulated, Mechanical Ventilator Splitter That Enables Differential Compliance Multiplexing

Cited by 4 publications

References 14 publications

Automatic air volume control system for ventilation of two patients using a single ventilator: a large animal model study

Automatic air volume control system for ventilation of two patients using a single ventilator: a large animal model study

Quantitative Comparison of Ventilation Parameters of Different Approaches to Ventilator Splitting and Multiplexing

Engineering Solutions to Biologic Challenges Exemplified in Times of Crisis

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