| NSF Org: |
IIS Division of Information & Intelligent Systems |
| Recipient: |
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| Initial Amendment Date: | May 20, 2020 |
| Latest Amendment Date: | January 22, 2021 |
| Award Number: | 2028709 |
| Award Instrument: | Standard Grant |
| Program Manager: |
Wendy Nilsen
wnilsen@nsf.gov (703)292-2568 IIS Division of Information & Intelligent Systems CSE Directorate for Computer and Information Science and Engineering |
| Start Date: | June 1, 2020 |
| End Date: | March 31, 2021 (Estimated) |
| Total Intended Award Amount: | $185,037.00 |
| Total Awarded Amount to Date: | $185,037.00 |
| Funds Obligated to Date: |
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| History of Investigator: |
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| Recipient Sponsored Research Office: |
1523 UNION RD RM 207 GAINESVILLE FL US 32611-1941 (352)392-3516 |
| Sponsor Congressional District: |
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| Primary Place of Performance: |
1 University Drive Gainesville FL US 32611-2001 |
| Primary Place of
Performance Congressional District: |
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| Unique Entity Identifier (UEI): |
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| Parent UEI: |
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| NSF Program(s): | COVID-19 Research |
| Primary Program Source: |
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| Program Reference Code(s): |
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| Program Element Code(s): |
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| Award Agency Code: | 4900 |
| Fund Agency Code: | 4900 |
| Assistance Listing Number(s): | 47.070 |
ABSTRACT
The goal of this project is to develop technology that can improve patient care and increase patient safety during pandemics such as COVID-19 that flood medical facilities. This project will develop an inexpensive, portable, in-circuit respiratory monitoring technology that enables safe and effective care of multiple patients needing ventilation during a crisis when facilities and clinicians are stretched thin. The system can provide remote alarms and monitoring of any ventilated patient -- saving clinical time and precious personal protective equipment (PPE) required to enter a COVID-19 isolation room, as well as dramatically increasing safety when using emergency ventilators. The system will also be designed to provide decision support in a rapidly changing environment and can collect important data for analysis of patient physiology to also improve care. The system also includes the ability to individualize treatment and monitoring to provide safe and effective ventilation of multiple patients on a single ventilator.
The planned design is the result of the team's long experience with ventilator and respiratory monitor design and is based on existing medical device software and proven ventilator technology. The system has been designed to use novel algorithms and sensing, while being rapidly manufactured with off-the-shelf components where possible. Other critical components that may be unavailable due to the crush of the pandemic have been designed to be easily 3D printed or injection molded, based on existing, proven designs. The team propose to build a monitoring and control device using an inexpensive tablet as the user interface and a smart sensor using Internet of Things (IOT)-based processor boards to monitor and collect data and provide safety advice to the over-worked clinicians. A safe, easily manufactured, modified pneumatic exhalation valve controlled by the monitoring system with pressure from the airway circuit itself will be added to individualize treatment for patients sharing a ventilator. This project provides the monitoring and control to safely and effectively use existing tools to ventilate patients. Beyond its pandemic uses, next generation versions of the technology can be used in isolation rooms of the future and also in resource-limited areas of the country and the world.
This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
PROJECT OUTCOMES REPORT
Disclaimer
This Project Outcomes Report for the General Public is displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed in this Report are those of the PI and do not necessarily reflect the views of the National Science Foundation; NSF has not approved or endorsed its content.
During the COVID-19 Pandemic and potential future outbreaks, the number of ventilators in a hospital or facility may not be sufficient to ventilate the influx of patients. In the early days of COVID-19 in the United States and other locations, many rapid prototype ventilators and methods of ventilating multiple patients on a single ventilator were proposed. However, several articles, including one from the major respiratory and intensive care associations, were published to point out the dangers that could occur from ventilator sharing or use of inadequately monitored ventilators. This project has created an inexpensive, rapidly producible, ventilator monitoring system and ventilator sharing system that provides safe effective ventilation in times of critical ventilator shortages.
The VentGuard Monitoring system consists of a front-end transducer system derived from a commercial respiratory monitor that is removably attached to a disposable airway sensor that can be 3D printed in emergencies or injection molded for mass production. This transducer system communicates directly with a low-cost Android tablet (Samsung) that runs a modified version of the RANDI software. The VentGuard Sharing System includes the VentGuard Monitoring System and a disposable pneumatic flow control valve for independently controlling ventilation to each patient. The system allows for complete monitoring (with alarms) and independent control of multiple patients on the same ventilator. In addition, the system supports remote monitoring to reduce the use of personal protective equipment (PPE) during pandemics.
A 3-day animal study was designed and implemented at Duke University to validate the performance of the devices. The two goals for the testing were: (a) to evaluate the VentGuard Monitoring System by comparing it with a commercial respiratory monitor (NM3, Philips Healthcare), and (b) evaluate the VentGuard Sharing System by ensuring that it safely and reliably obtained and maintained the desired settings for individually ventilating two animals on one ventilator. For the VentGuard Sharing System, the system was evaluated with both healthy, sick, and a combination healthy and sick animals simultaneously.
The VentGuard Monitoring system was evaluated across 19 different ventilator settings using ten different measured parameters. All 10 settings were accurate within 10% of the NM3’s values with a p-value < 0.001 (N=2410 breaths) as required by FDA. The VentGuard Sharing System was tested to ensure it could individually control tidal volume and pressure to the two animals at different settings and different conditions for the animals. The bias for the pressure target system was -.277 cm H20 and the precision was +/- 0.36 cm H20. Both of these values are clinically insignificant and less than 3% of the set value. The bias for the volume target system was -0.67 ml and the precision was +/- 10 ml. Both of these are also clinically insignificant and less than 3% of the set values.
This project produced an easily manufacturable, inexpensive, methodology for monitoring and sharing ventilators during pandemics. The system was built for less than $250 each and performed well within specifications during 3 days of animal testing.
A patent with the design was disclosed.
Last Modified: 05/02/2021
Modified by: Jose C Principe
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