Georgia Institute of Technology

Mar 7, 2022

An interdisciplinary team led by Omer Inan, associate professor in the School of Electrical and Computer Engineering (ECE) at the Georgia Institute of Technology, including collaborators from Emory University, Children’s Healthcare of Atlanta (Children's), and the Global Center for Medical Innovation (GCMI), has won the Presidents’ Award of Distinction for Team Science from the Georgia Clinical and Translational Science Alliance (Georgia CTSA).

The award is presented annually to a multi-disciplinary research team for “innovative and impactful research that has, or will likely, advance clinical and translational science and positively impact human health,” according to Georgia CTSA, a National Institutes of Health-funded initiative that brings together the University of Georgia, Emory, Georgia Tech and the Morehouse School of Medicine to facilitate clinical and translational research.

“From the start the team has prioritized inclusivity, which is key to maximizing the potential of new technologies to impact society through commercialization or application in patient care settings. We've been very careful to make sure all voices are heard,” said Inan.

The “IV Infiltration Detection Technologies Research Team” is recognized for creating a new biomedical device that monitors for important safety issues that can occur during intravenous (IV) therapy – the process of delivering liquids or medicines through a needle directly into a patient’s veins. The technology has the opportunity to be successfully commercialized for improving patient safety of those receiving IV therapy around the world, especially children

“It’s very exciting that this innovative, high-functioning research team has been honored with the Georgia CTSA Presidents’ Award,” said Julia Kubanek, vice president for Interdisciplinary Research. “Because of this research collaboration between Georgia Tech, Emory, Children's and GCMI, one of the biggest problems affecting patient safety in hospital settings might finally be solved. Georgia Tech is grateful to the Georgia CTSA to be part of this distinction and its help in accelerating the impact of our research in Georgia and beyond.”

Inan, the ECE Linda J. and Mark C. Smith Chair, is the principal investigator (PI) of the effort and conceived the wearable multi-modal sensing architecture and developed the engineering plans for translating the technology from concept to prototype to preclinical testing and ultimately human subjects testing. Inan incorporated past research on wearable biomedical technology for monitoring things like knee and joint health throughout device development.

The team includes experts in sensing and machine learning for health, pediatric intensive care, vascular access and care, and medical device design and development.

“To address problems this big, you need a big team with more expertise than the narrow technology-focused faculty member and Ph.D. student may have within a given lab,” said Inan.

Members of the award-winning team include:

• Sherry Farrugia, chief executive officer of the GCMI. Farrugia has cultivated the relationship between Georgia Tech and Children's and provided immense support with legal agreements and visibility. She has worked with the team to ensure that regulatory and medical device translation elements are incorporated into the plans.
   
• Mike Fisher, director for product development at GCMI. Fisher worked with Inan and Mabrouk to collaborate on the packaging and cleaning of the wearable prototype in preparation for use in the human subject study at Children's.
   
• Kevin Maher, professor of pediatrics and pediatric cardiologist at Emory School of Medicine. Maher is the Co-PI and serves as the clinical lead for the overall effort.
   
• Samer Mabrouk, research engineer at Georgia Tech ECE. Mabrouk was the lead Ph.D. student on the project from 2017-20 and has been the technical lead on the project as a postdoctoral researcher since 2020.
   
• Amy Parker and Lynn Pogue, registered nurses at Children's. Parker and Pogue were the caregivers that first brought the clinical problem to the attention of the Georgia Tech and Emory team. They have been involved from the start of the project and have provided support, clinical expertise, and user feedback throughout the design process.
   
• Zahidee (Saidie) Rodriguez, pediatric intensivist at Children's. Rodriguez is the key partner for the observational clinical study and facilitated and overseen the data collection and collaborated with the engineering team for data interpretation.
   
• Leanne West, chief engineer for pediatric technologies at Georgia Tech. West contributed intellectually to the project from the start and worked with Farrugia to support the collaborative interactions with the team.

Research by the team began in 2014 when West surveyed doctors and nurses at Children's and learned IV infiltration was cited by many as a major challenge within the field. She reached out to Inan and Maher to form a team to collaborate on the formulation of an innovative, wearable sensing-based medical device for early detection of peripheral IV infiltration and extravasation (PIVIE) events. PIVIE events occur when a fluid leaks outside the vein into the surrounding tissue. Depending on the contents of the IV solution, the effects can range from swelling to blisters, severe tissue injury, or even necrosis.

The team’s innovative multi-modal sensing design has been recently validated in preclinical and observational clinical studies. The team now plans to incorporate a detection alarm with wireless communications in the device to alert caregivers of a PIVIE event, conduct a clinical study to demonstrate safety and effectiveness of the device and algorithm, and submit paperwork for 510(k) clearance from the FDA towards commercialization.

As the winner of the President’s Award of Distinction for Team Science, the team will receive $5,000 towards furthering their work. They were recognized at the 2022 Southeast Regional Clinical and Translational Conference (March 3-4, 2022).

Read more about the team’s research and findings in Innovative IV Sensor Moves Closer to Clinical Trial.