The Vent Multiplexor is a patent-pending emergency co-ventilation device intended to provide individualized temporary rescue mechanical ventilation during the COVID-19 pandemic. Developed in collaboration with Yale-New Haven Hospital and granted Emergency Use Authorization by the FDA on April 15, 2020, the Vent Multiplexor has the potential to help reduce the clinical need for ventilators during the COVID-19 pandemic, as it permits the emergency sharing of ventilators between two patients who are not equally matched, by delivering individualized tidal volumes, while also providing critical validation data on the quality of patient matching using existing “T-connector” and similar ventilator splitting technologies, a potentially revolutionary paradigm shift in the delivery of pandemic emergency respiratory care.
VENT MULTIPLEXOR FREQUENTLY ASKED QUESTIONS
What is dual patient ventilation?
Dual patient ventilation (co-ventilation) is a novel concept and design outside the standard practice of critical care medicine, which contemplates the use of a single ventilator for each patient requiring mechanical ventilation. However, with the sudden onset of the COVID-19 pandemic, an acute worldwide shortage of critical care ventilators has emerged. In response, a number of strategies and rescue techniques for the emergency sharing of a single ventilator by two patients has emerged, when individual ventilators are not available, or in order to preemptively increase the potential of single-use ventilators by permitting mechanical ventilation for multiple patients simultaneously.
Is there more than one way to achieve dual patient ventilation?
Yes. The first method of dual patient ventilation to receive FDA Emergency Use Authorization during the COVID-19 pandemic was a splitting device called the Vesper. T and Y splitting devices like the Vesper simply split the ventilator output into two circuits and deliver the same treatment to both patients. Splitting a ventilator in this manner remains controversial within the medical community and has been opposed by the majority of critical care societies because it does not permit individualized patient treatment, potentially compromising the care of one or both patients in the process. Given the inability to individualize therapies, these splitter type devices caution that patients be matched for size and disease state, which is nearly impossible in a crisis care environment. Other methods of rescue co-ventilation have been proposed, including pressure-mode co-ventilation, however, pressure modes are challenged in obtaining ARDSnet compliance, as these modes are unable to regulate tidal volumes, and the devices that would be employed to use them have either not been tested in a clinical setting with patients or have not been authorized by the FDA for emergency use during the COVID-19 pandemic. The Vent Multiplexor has been clinically deployed with COVID-19 patients, it is authorized by the FDA for emergency use during the COVID-19 pandemic, and it enables individualized therapy through the regulation of tidal volumes delivered to each patient during co-ventilation.
How does the Vent Multiplexor Work?
The Vent Multiplexor allows for individualized therapy to be delivered to each patient during emergency dual patient ventilation. The Vent Multiplexor is designed using two Venturi tubes to measure flow and thus infer volume delivered in the closed ventilator circuit. Using two adjustment devices and by continuously measuring flow in the Venturi tubes, tidal volumes can be adjusted uniquely for each patient to equally or unequally split the ventilator output as desired by the clinician. As a result, the Vent Multiplexor helps obviate the need for precise patient size and disease state matching. Moreover, with careful implementation, the Vent Multiplexor preserves many of the crucial monitoring parameters that only a single critical care ventilator can currently provide. With the ongoing ventilator shortage across the United States due to the COVID-19 pandemic and continuing questions concerning the efficacy of certain emergency ventilators being used in response to the crisis, the Vent Multiplexor has the potential to materially reduce clinical need for ventilators, as it permits sharing of critical care ventilators between two patients who are not equally matched, while maintaining the critical care standard of care. In addition, even when used in passive mode, without adjusting tidal volume, the Vent Multiplexor acts as a validation tool on the quality of patient matching when using existing splitter technologies like the Vesper for co-ventilation, a potentially revolutionary paradigm shift in emerging pandemic emergency respiratory care.
Is the use of the Vent Multiplexor authorized by the FDA?
Yes. The Vent Multiplexor has been authorized by the FDA under an Emergency Use Authorization. The Vent Multiplexor is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of ventilators, ventilator tubing connectors, and ventilator accessories under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. The Vent Multiplexor has not been approved or cleared by the FDA. For more information concerning the emergency use of certain medical devices during the COVID-19 pandemic, please visit https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19.
How was the Vent Multiplexor Developed and Tested?
The Vent Multiplexor was developed by Pulmonary and Critical Care physicians in collaboration with Yale-New Haven Hospital, fully cognizant of the importance of volume modes of ventilation in the setting of ARDS physiology such as COVID-19. The Vent Multiplexor has been robustly tested using the Certifier FA Plus (TSI Inc), as well as deployed by Yale-New Haven Hospital in a pandemic setting, and has functioned precisely as intended. During clinical deployment with advanced ARDS COVID-19 patients, the Vent Multiplexor was adjusted to provide individualized therapies as dictated by arterial blood gas results, with the final resulting blood gasses during the deployment achieving the improvements desired by the treating clinicians. To watch a video by the Yale School of Medicine discussing the Vent Multiplexor clinical deployment please visit https://www.ventmultiplexor.com.
Does the Vent Multiplexor Operate in “Pressure Mode?”
Yes. However, even though the US Public Health Service Commissioned Corps currently recommends the use of pressure modes during emergency co-ventilation, it is not always appropriate for emergency co-ventilation because, among other things, pressure modes are unable to regulate tidal volumes, and instead focus on regulating the pressure within the circuit. As a result, whenever clinically appropriate and with the use of alarms and pressure limits available on critical care ventilators, volume modes of ventilation are preferred for patients with ARDS, such as those with COVID-19. The Vent Multiplexor enables standard of care ARDSnet compliant individualized ventilation therapy through the regulation of tidal volumes delivered to each patient during co-ventilation.
Is the Vent Multiplexor easy to deploy in clinical settings?
Yes. The Vent Multiplexor provides a turnkey solution to ensuring standard of care ARDSnet compliant ventilation of 4-8cc/kg of ideal body weight when splitting ventilators during a pandemic such as COVID-19. The Vent Multiplexor is easy to use, with only one point of adjustment and monitoring for each patient to simplify workflow for nurses, respiratory therapists and physicians. The Vent Multiplexor is easily integrated into ventilator circuits and is deployed with a comprehensive set of clinical protocols to ensure ease of use during co-ventilation. Through the use of the Vent Multiplexor protocols, which include step by step instructions and photos of setup and monitoring, the Vent Multiplexor can be understood and deployed for dual patient ventilation in just a few minutes.
How much does the Vent Multiplexor cost?
The Vent Multiplexor Co-Ventilation Kit cost $999 US dollars and contains 5 disposable Vent Multiplexor units and tubing, as well as a set of reusable clamps (additional clamp sets sold separately). Each individual Vent Multiplexor unit in the Kit is intended for one co-ventilation deployment with a critical care ventilator and is intended to be discarded following the removal of either patient from the co-ventilation circuit. Vent Multiplexor recommends maintaining on hand for emergency co-ventilation at least one Vent Multiplexor Co-Ventilation Kit for each critical care ventilator.
How do I order the Vent Multiplexor?
The Vent Multiplexor is available for immediate purchase for hospitals and other clinical care settings directly from Vent Multiplexor LLC as well as through authorized Vent Multiplexor distributors. For more information please visit https://www.ventmultiplexor.com/contact or contact Vent Multiplexor directly by telephone at (646) 442-3453 or by email at email@example.com. The Vent Multiplexor generally ships within three business days.