A U-M otolaryngology team has designed an innovative trach plug for patients who either no longer need a tracheostomy tube or require support only intermittently.
Catie Carroll attended prom this year in a red full-length dress, pearl earrings and matching necklace.
But one usual item was missing from her neck: a tracheostomy tube.
Because of a rare condition that prevents her body from eliminating carbon dioxide on its own, Catie, 17, has long relied on a trach tube to do the job for her. Since birth, the tube that protrudes from her neck has been a part of everyday life.
But thanks to a new 3D-printed custom device created by the Michigan Medicine otolaryngology team, the high school senior could attend prom trach tube-free.
For a select group of patients with a tracheostomy, a surgical opening in the neck that allows access to the windpipe to help patients breathe, the novel silicone plug eliminates the need for 24/7 use of a trach tube.
Using a 3D printer, U-M teams custom-fit the stretchy, skin tone-colored device for every patient.
‘Positive changes’ in pilot study
Michigan Medicine otolaryngologist Kyle VanKoevering, M.D., says he designed the plug as an alternative for patients who did not need a trach tube around the clock and who were experiencing skin irritation, pain with swallowing and other issues because of constant use of the tube.
“There were few options that were easy to manage at home, seamless and cosmetically appealing for patients who either only needed a trach tube part time or no longer needed a trach but did not want to surgically close it,” says VanKoevering, who treats both adult patients and children at University of Michigan C.S. Mott Children’s Hospital.
“We wondered if there was a better way to treat this population of patients,” he says. “After six different designs, we found something we believed would work and got approval for a pilot study to see whether this device was safe and feasible.”
Findings are preliminary, and the device — financially covered by institutional funding — is not approved by the Food and Drug Administration.
The pilot study includes 25 patients ages 17 to 70 who meet the criteria to use the plug.
Some patients are already reporting benefits, from increased comfort to more confidence going out to dinner and even being able to wear a tie for the first time.
“We are so far seeing positive changes in skin irritation, voice, swallowing function and social isolation issues among several of our patients,” VanKoevering says.
Living with a trach tube
A tracheostomy can be a lifesaving or life-sustaining intervention. But there are risks involved with surgically closing the hole in the neck when the trach tube is no longer required, including recurrent pneumonia and aspiration, ineffective cough and skin irritation.
Some patients are also at high risk of serious complications from surgically closing the trach.
Other patients need only temporary or intermittent tracheostomy access.
Such is the case for Catie. She has a rare condition called cerebrocostomandibular syndrome that prevents her ribs from growing at the same pace as her body. Because her lungs are smaller than usual, she needs ventilated support — but only for five to six hours at night while sleeping.
The custom-fitted plug eliminates air flow through the tracheostomy, plugging the tract so that Catie can enjoy her days without the trach tube, replacing her trach only at bedtime when she needs it.
Her mother, Traci Reedy, says she designed trach ties in different colors and styles, including polka dots, to prevent the trach tube from making Catie uncomfortable in social situations.
But even in their supportive Rochester, Michigan, community, it was easy to get self-conscious.
“I used to call her my shadow because she always walked a few steps behind me,” Reedy says. “I realized she wanted me to shield her from people who might stare at her.”
Reedy says the 3D device has made a huge difference in her daughter’s life.
“Her confidence has gone up tremendously,” Reedy says. “You can tell in her posture and the way she talks to people and interacts in public. She’s just thrilled to have more normalcy as a teen.”
New freedom, new firsts
Dominic Sirbaugh, 20, has Klippel-Feil syndrome, which restricts his breathing at night. Since he was a baby, he has used a trach tube for ventilator support to help him breathe.
But as a high school senior, he enrolled in the study and started using the trach plug.
“I wore a tie for graduation,” he says. “That was the first time I’ve ever been able to do that.”
The Jackson, Michigan-area college student, who plans to go into culinary arts, says he is much less self-conscious when he’s out in public.
“It’s changed my life,” he says. “I didn’t like going out before because people would stare. It was also uncomfortable and irritated my skin.”
“I go everywhere now,” Sirbaugh says. “I go out to dinner with my friends and walk around campus with freedom from the trach tube.”
Both Sirbaugh and Reedy say the innovative approach is a telling example of how much their care teams want to improve patients’ lives.
“For doctors to think about how to make life better for patients from all aspects, not just their medical condition but their quality of life after they leave the office, that’s pretty extraordinary,” Reedy says. “It shows how much they care.”