Ventilator Shortages in the COVID-19 Pandemic
The Need for Efficient Ventilation
Predicted shortage of 960,000 ventilators in the USA.
The COVID-19 pandemic has severely outpaced the capabilities of healthcare systems worldwide to procure, produce, or adapt the available tools. Mortality in COVID-19 patients often occurs by respiratory failure due to acute respiratory distress syndrome (ARDS). ARDS is ideally managed through intubation and lung-protective ventilation using intubation. However, the volume of COVID-19 patients susceptible to ARDS is much greater than the number of ventilators available at most hospitals and clinics, leading to extremely difficult triage decisions. Thus, there is a dire need for effective, low-cost, rapidly deployable, and easy-to-use ventilation strategies to combat the COVID-19 pandemic.
COVID-19 projections from the Institute for Health Metrics and Evaluation, Univeristy of Washington. To visit the full site, click here.
Splitting of one ventilator to multiple patients has been proposed as a potential solution and performed in a few emergency cases. This involves connecting multiple outflow tracts to the ventilator to divide flow amongst the patients. This approach is immediately scalable and permits use of ventilators already familiar to clinicians by utilizing readily available tubing and ventilatory equipment.
However, this approach can yield patient interdependence which poses the following major safety concerns:
- Independent control of volume and pressure to each patient is not possible.
- Changes in one patient’s condition (clinical improvement or deterioration) results in an automatic change to ventilation of other patients.
- Sudden events such as pneumothorax, tube occlusion, or disconnection of an endotracheal tube, causes harmful imbalances of ventilation that are potentially deleterious for other patients.
- Cross contamination of airborne pathogens across channels can occur.
- Alarm monitoring is challenging due to a complex circuit configuration.
These limitations have limited widespread adoption of splitting ventilators. Our work aims to overcome these limitations.
iSAVE: A Patient-Specific Ventilation Expansion System
Our Individualized System for Augmenting Ventilator Efficacy (iSAVE) repurposes existing medical flow valves to allow a single ventilator to provide personalized support to at least two patients. iSAVE enables independent control of volume and pressure for each patient and incorporates safety measures to accommodate sudden patient deterioration and cross contamination. Leveraging off-the-shelf components, the iSAVE can facilitate a rapid expansion of the ventilation capacity of hospitals.
This system has been designed specifically for the management of ARDS during the COVID-19 pandemic. It has been validated on ICU ventilators and in vivo animal models. The cost of iSAVE components for each patient is ~$25 and takes less than 10 minutes for assembly and testing.
The iSave team is currently engaging with third parties in order to proceed to apply for Emergency Use Authorization from the United States FDA in order for iSave to be used in healthcare settings to support patients during the COVID 19 pandemic.
This website provides information on the following:
- Implementation: provides information on the system design, required components and instructions on assembly and use
- Validation: reports benchtop and in vivo results
- Potential Clinical Considerations: suggests considerations for clinical implementation. (Note: iSAVE is an early experimental system which has been validated in pigs and is currently not approved for human use. We are in the process of applying for an Emergency Use Authorization from the Food and Drug Administration for patients with COVID-19.)