By JAMES BELL
It’s said necessity is the mother of invention, and one Fort Hays State University student saw a problem in a widely used and often deadly medical practice and immediately went to work on finding a solution, developing a system that has the potential to change medicine forever and save countless lives.
In layman’s terms, the problem is simple. During a procedure known as Advanced Cardiovascular Life Support, a more medically advanced version of CPR, medical practitioners can give too much air to a victim, causing widespread damage to the body, complicating recovery and resuscitation, often resulting in death.
But as studies have shown the dangers and training emphasizes the importance of correctly administering airflow during ACLS, FHSU virtual college student Bobbi Sue McCollum has developed a simple solution to ensure only the correct amount of air is given to a patient. Her device could significantly improve the chances a patient will survive and be able to return to a normal life after the procedure.
“I couldn’t believe it when I left ACLS (training). There is nothing stopping anyone, with good intentions even, from hyperventilating people, and I knew there was probably some simple solution,” she said. “And I was sure that I could figure it out.”
And, if the excitement around the project is any indication, she did just that.
Goldilock valves give feedback to the operator, stopping the ability to compress air too many times during ACLS.
“With my system, you look at the patient and estimate their size – it is actually possible to estimate the amount of air someone needs by looking at them – so I made a system based on that,” McCollum said.
The valve which is attached to a bag which pushes air to the patient is adjusted to the patient’s size and regulates the flow of air into the bag.
“You click it to that space and then it refills the bag a little slower,” she said. “When you feel it is fully re-inflated, five seconds has passed and it’s time to compress the bag again.”
There is nothing like this device currently available on the health care market.
Air given during resuscitation when used properly should give 10 to 12 breaths per minute, but despite training, practitioners often triple that amount, causing hyperventilation.
“You have to imagine a scenario that someone is dying in front of you, six seconds is an eternity in that scenario,” McCollum said. “Studies show we’re doing it 30 to 37 times a minute we’re a compressing the bags.
“That’s correlated with a significant reduction in survival.”
While there is little data on the effect in humans available due to rising concerns in the medical community of admitting fault, it is a well-known and widespread problem.
“What’s interesting about this, they did all these animal studies and they know there is a decreased survival (rate),” she said.
Those numbers are hard to quantify to human patients, however, because medical providers are reluctant to assess the rate of hyperventilating rates because of liability issues, McCollum said.
“That’s a problem with medical culture. We are so afraid of being sued we have a problem really recognizing our own downfalls,” she said.
She believes this could be the biggest challenge in getting the device through the trial phase.
In one trial that she cited, human analog — pigs — were given proper respiratory rate and six out of seven lived. A second group given too much resuscitation — only one survived.
“We know it’s a problem. I don’t think the public understands the gravity of the problem,” McCollum said. “It is true that it happens frequently, but we didn’t know at the time it was so bad.”
Hyperinflation causes damage to the lungs, pushes air in the stomach and can create pneumonia from vomiting, which is one of the top reasons of death in intensive care units.
“The worst part is your lungs get so expanded they actually compress your heart down, so your heart has less and less room to refill with blood and push it back to your body,” McCollum said.
This starves the body from oxygen, including the brain.
“So the longer your code goes for the less and less likely if you are being hyperventilated the less and less likely you will come out with baseline neurological status,” she said.
The Fort Hays Connection
While McCollum lives in Oregon, she is originally from Nebraska and searched the area for a program to complete a bachelor’s in nursing and found FHSU to be a perfect fit.
“There is this huge push to have all RNs have bachelor’s, and they’re are really expensive programs mostly all over the country,” she said. “But I knew, since I was from the Midwest, I could get a good deal in the Midwest.
“Fort Hays has a great reputation, they have all the right accreditations that you need and they are really flexible. I could take it as slow or as fast as I wanted,” McCollum said.
She plans to graduate in December and, after working on the degree for over two years, and has found FHSU community connections even in Oregon.
“There are a lot of Fort Hays students out here,” she said. “There is a whole bunch of nurses that go to Fort Hays out here.”
The Next Step
Even as the device is still in development, the push to get to the field is strong — the faster it gets to market, the quicker patients will benefit from the life saving device.
“This month, I’ll have my third generation prototype come out,” McCollum said.
She is working with an air flow and mechanical engineer on the newest model.
Originally, she developed a two-valve system, based on average lung function, which wouldn’t work for every patient — so work continues to make it even more versatile.
“The new solution is even more simple, it’s elegant and it works for every patient,” she said.
That model is set to be released this week.
“I don’t think it will take much more to release a solid adult model,” McCollum said.
And work will not stop there. In January, a crowd-funding campaign is planned in order to develop a pediatric version of the device.
After the development is finalized, it will go to the FDA for approval, because the device is altering an existing device, it should move into a higher level of FDA testing, rather than the full line of testing, which usually takes years of research.
“I think we’re going to do a research trial and we have potentially contacted a place that will do research,” McCollum said. “I expect that once we do that, it shouldn’t take long to actually to be able to market it.”
While a device like this could net huge profits, she it not interested in creating a medical device empire, instead she simply wants to improve patient care. She said medical equipment marketing companies are pushing for moving the product along so the device can move into medical practices.
“I don’t want to manufacture or deal with any of that, I really just want to create this so we can stop hurting people when we are trying to help them,” she said.
She has no expectations of making huge profits from her device.
The Process and Expectations
Even with proper training, McCollum studied what actually happens during ACLS and thought there has to be a way to make the procedure better.
“My ‘eureka moment’ is when I pictured how it actually happens,” she said. “What they are actually doing is grabbing the bag, squeezing until their fingers touch, and then as soon as it re-inflates, they hesitate slightly then compress again. All I need to do is slow down the refill so they can feel that it is time to compress that bag again.
“I really think this whole thing is going to change the standard of care.”
She is especially hopeful that the biggest use of the device will help save soldiers in the field.
“In the military, we have all of these young guys that have strong healthy bodies that get trauma,” McCollum said, which makes them prime candidates for a form of resuscitation not complicated by disease.
She currently has provisional patents that could further development before the official submission and, as work continues, the final patent may be granted on the final form of the product, rather that its current iteration. Even with development still in progress, the outlook is good for McCollum and the patients her device will save.
“I feel so confident that I have created this concept that will save lives,” McCollum said.
For more information about the device and studies on the subject, McCollum has a website that can be visited here.