Taking the pressure out of intubation

UNC researchers, with support from FastTraCS, are developing a new way of securing endotracheal tubes that could reduce injuries.

A person comes into the hospital with a bad cough and shortness of breath. Their blood oxygen levels are low, and clinicians soon discover they have a serious case of pneumonia and need emergency support. So, after the patient is sedated, an endotracheal tube, or breathing tube, is placed into their windpipe and connected to a ventilator to provide them with oxygen.

The emergency is averted, but the patient needs to stay in the hospital, and on the ventilator, so their lungs can heal. That's when a whole new challenge arises.

Endotracheal tubes are usually secured to a patient's face with tape, adhesives, straps, or other devices that prevent the tube from accidentally jostling or dislodging. As time goes by, these devices can press down on the person's face, restricting blood flow and causing the skin underneath to slowly break down—and if left unchecked, this pressure can create a deep wound, leaving the patient with scars long after they've been taken off the ventilator.

These "pressure injuries" from intubation can be painful, and sometimes even require plastic surgery to fix, making the hospital stay even more complicated for patients who are already facing serious illness.

But now, a group of UNC researchers is trying to make these complications a thing of the past through a project coordinated by FastTraCS, the biomedical engineering and commercialization division of the North Carolina Translational and Clinical Sciences (NC TraCS) Institute. The team is developing a mouthguard that could secure an endotracheal tube without putting pressure on a person's skin—helping to limit the potential for complications during this life-saving procedure.

"You can just see that in your effort to save somebody's life with an intubation, you're also causing suffering," says Kim Young, a clinical senior management engineer at UNC Hospital's Office of Quality Excellence, and a member of the research team. "Trying to prevent that suffering for people is really important."

The seeds of this project came from the early days of the COVID-19 pandemic. As the virus overran hospitals, clinicians discovered that intubated COVID patients tended to fare better in the prone position, or lying on their stomach with their head lying cheek-down. But this meant sedated patients were left with the device holding the tube squeezed between their cheek and the bed.

"Your face is resting on that hard piece of plastic," says Nicole Wiley, a prototype and design engineer at FastTraCS, and another member of the team. "And when you're unconscious you can't feel that that's uncomfortable."

As a result, many COVID patients left the hospital with severe pressure injuries. "We were having a lot of patients with full-thickness skin loss under the securement device that we normally use," Young says. "They would lose their skin down to the bone and need plastic surgery afterwards."

To solve this problem, the research team searched for an alternative way to secure an endotracheal tube that avoided contact with the skin. Austin Rose, a pediatric otolaryngologist at the UNC School of Medicine, and another researcher on the project, had an idea—what if they attached it to the teeth instead?

The team devised a mouthguard that can mold to a patient's jaw. When someone needs to be intubated, a clinician can fill the mouthguard with putty and create an imprint of their teeth. That putty quickly hardens, securing the mouthguard around their teeth like a puzzle piece. The endotracheal tube then can be strapped directly onto the bottom of the mouthguard, with nothing touching the patient's skin.

Additional design details address some other common issues that arise during intubation. For one, the mouthguard is flexible enough to remove for regular teeth cleaning, Wiley says. It also has a built-in bite block between the top and bottom teeth to prevent patients from accidentally clamping down on the tube and cutting off airflow.

The device still needs to undergo further testing and clinical trials before it could be used in the hospital. But the team has now received a provisional patent for their design, a key step on the road toward potential FDA approval and commercialization.

FastTraCS has been a key player in getting this project off the ground. Young, who initially raised the challenge of intubation pressure injuries, is a member of FastTraCS' advisory group, as are Rose and UNC School of Medicine physician Robert Lampman, the final member of the team. Wiley, who works with FastTraCS to help clinicians solve problems like this, worked out many of the mouthguard's design specifications. And Young says that Andy Kant, the director of FastTraCS, is "so knowledgeable about how to take a good idea and turn it into a real-life strategy."

Young and Wiley both say healthcare workers inherently understand the device's potential value. "We showed it to some of our friends who are respiratory therapists, nurses, medical directors—they all thought we were on to a really good idea," Young says. "They kept telling us: keep going."

Clinicians have also pointed out how this device could help groups of people who face unique challenges during intubation. Some people, for example, sweat a lot, making it hard to use tape or adhesives to secure a tube to their face. The same goes for patients with beards, who often need to be shaved so the tube can be secured.

Perhaps most importantly, the device could offer an alternative method of intubating patients with severe burns. Burn patients often also have lung injuries from smoke inhalation, requiring them to be placed on a ventilator. But it can be hard to safely secure the endotracheal tube on their extremely fragile skin, so clinicians sometimes need to suture the device onto the patient's face, Young says. This mouthguard would eliminate the need for anything to touch their skin.

"I just think it's really neat that this has the potential to change the way tubes are secured," Wiley says. "I think we're going to keep finding uses for this beyond the ICU."