USU Med Student Develops Monitoring Device for Neonatal Tracheostomy Patients

By Vivian Mason

U.S. Air Force 2nd Lt. Conrad Dear, a second-year medical student at the F. Edward Hébert School of Medicine at the Uniformed Services University of the Health Sciences (USU), has developed, along with a team of four other engineers, a unique monitoring device—called the “TrachTracker”—for neonatal tracheostomy patients. It’s currently undergoing utility patent approval.

As a college senior and biomedical engineering major at North Carolina State University, Dear was required to complete a senior design project.  He decided to embrace an idea he had been thinking about since he had been a research scholar in the JACK’s Summer Scholars Program at Virginia Commonwealth University’s School of Medicine between his junior and senior years. 

“Basically, I did research in the NICU [Neonatal Intensive Care Unit],” he stated. “I was doing outpatient rotations with a few neonatologists, and one day we saw a young mom whose baby had a tracheostomy tube in place. The baby started to cry, but there was no sound. I was intrigued.” 

The mother talked to them about the trouble she was having while trying to care for the baby. She didn’t have a lot of money for an in-home nurse, so she stayed at home to care for him. The mother also discussed the fact that she had serious difficulty identifying if the baby needed anything because he couldn’t communicate or give any audible signals. 

USU medical student, 2nd Lt. Conrad Dear,
was one of 5 inventors of a new device to help
infants with tracheostomy tubes communicate
distress. (Courtesy of Air Force 2nd Lt.
Conrad Dear)

“I didn’t really think too much about a solution right then,” says Dear. “But, I thought the situation was really unfortunate. I’d never seen a case like that before. The doctor said that there was nothing particularly helpful, short of recommending that the mother hire an at-home nurse. Otherwise, there was only the respirator and pulse oximeter to alert the mother if the baby was in major distress. So, I decided to think about this situation some more once fall semester started.”

Ultimately, that thinking led to it becoming his senior design project, which involved a strong collaborative effort of four other team members. Once the team investigated the issue and figured out a solution to the problem, they spent the entire school year prototyping the monitoring device. They also met with doctors and nurses from the North Carolina Children’s Airway Center who were very receptive to the TrachTracker and who provided support.

“Our university really believed in us,” says Dear. The team won a lot of competitions with the TrachTracker, most notably the i4 Competition sponsored by the Joint Department of Biomedical Engineering at the University of North Carolina–Chapel Hill and North Carolina State University. This four-phased competition focusing on identification, ideation, innovation, and implementation awarded students a financial prize to support entrepreneurship that addressed real-world problems. The team decided to use the money to pay patent lawyer fees and continue prototyping. 

“The way the TrachTracker works is that it doesn’t require any new pieces of equipment to be put on the baby other than what the baby already has to wear,” he explains. “We didn’t want to give the parents a new attachment to worry about that required special guidelines or monitoring to make sure it was put on correctly,” says Dear. “What we really learned when working on the project was that parents just want to be able to trust the devices they place on their children. So, we adapted the existing trach tie that these children already have to wear and incorporated the TrachTracker inside, resulting in the babies not wearing any additional new parts. It’s like a high-end baby monitor.” 

The TrachTracker reads muscle activity off the neck, as well as heart rate. When the electrical readings from these two signals form the right combination, a computer algorithm recognizes it and produces an alert. The computer will output a message to the parents to let them know that their child is in a state of distress and needs some attention or comfort. 

The final TrachTracker design that will be covered by the pending utility patent. This electronic piece is what will be integrated into the soft cloth tracheostomy
tie around the baby's neck. (Image Credit: Courtesy of Air Force 2nd Lt. Conrad Dear)

Generally, in babies with tracheostomies, there’s a small opening (or stoma) in the windpipe/trachea. A tube, called a tracheostomy tube or “trach tube”, is placed through the stoma to help the baby breathe. Reasons for a neonatal tracheostomy typically include airway obstruction, neurologic impairment, or pulmonary insufficiency. All babies with tracheostomies have a little strap that goes around their necks to hold the tube in place and prevents the baby from pulling the tube out. This is known as a “trach tie.” 

When an infant has a  tracheostomy, all air travels through to the lungs and then exits out through the trach tube to the respirator and bypasses the vocal cords. Because of this, babies can’t make any noise because no air reaches the vocal cords. The TrachTracker is designed to seamlessly integrate into the already existing trach tie and reads data from the neck to let parents know that their child is in distress. 

“This is such a small patient population. Roughly 4,800 babies per year have this condition. Some of them recover in a few months. It’s not necessarily permanent. Our main goal was to build something actually useful to help these families,” Dear said. “The design structure of the TrachTracker has a lot of other possibilities that we haven’t had the time to explore. Currently, it’s designed to go around the baby’s neck. But it doesn’t necessarily have to be used around the neck or even for babies with tracheostomies. Eventually, it can be adapted for any child experiencing speech issues. Approximately 1% of all American children are unable to communicate through speech, which means that there are a lot of opportunities for the TrachTracker.” 

He’d like to see this monitoring device have broader success, either through a company showing interest or eventually reaching a real patient. “We talked to many parents about the TrachTracker to find out what they had to say,” he explains. “Their main concern was child safety. So, our first priority was always to make sure it was trusted by the parents.  Interestingly, plenty of studies show that parents who are less attentive to their children when they cry generally have kids who grow up with more social issues because they were consistently neglected. It’s hard enough for a baby with a tracheostomy, no less to add social issues to that scenario. Hopefully, the TrachTracker will help combat that as well.” 

2nd Lt. Conrad Dear's TrachTracker invention will help
infants with tracheostomies, similar to this one, convey
their distress to parents and caregivers.
(Courtesy of Amber Cox)

The team filed for a patent in 2019 with the United States Patent and Trademark Office (USPTO)  and also filed for a full utility patent (also called a “patent for invention”) that covers creation of a product and prohibits others from using the invention without authorization.  The utility patent application is currently in the examination stage at the USPTO and will be hopefully formally published within the next month, according to Dear. 

“The actual approval process to get a utility patent granted takes between three and four years so my hope is by the end of med school it will be done,” he said. “We also have a PCT application filed right now which is a worldwide patent application that gives privileges in other countries.”

The original design team is now spread out all across the country and involved in different ventures. However, North Carolina State University allowed them to pass the project on to another team that they handpicked. “We’re going to let them push it into the clinical research arena,” says Dear. 

Dear joined the Medical Innovations Interest Group at USU to continue his involvement with biomedical engineering and medical devices, where he can help develop, along with other USU students, creative solutions to clinical needs. He is currently the group’s lead engineer and vice president.  He also started a new biomedical device 3D printing research project at the Medical Applications Center at Walter Reed this year that consumes much of his time when not studying or seeing patients.