It’s a long-standing challenge for first responders: Opening the airways of critically injured patients struggling to breathe often takes multiple attempts, costing crucial seconds.
The problem caught David Haggerty’s attention when he was a graduate student, and he set out to see if he could make the rescue procedure, called intubation, easier. In a paper published WednesdayHaggerty and a research team led by the University of California, Santa Barbara, described a robotic device they say has the potential to be faster and more reliable.
Midway through the project, the work became unexpectedly personal for Haggerty when his cousin died in a motorcycle accident. In an interview with STAT, he said he couldn’t shake the feeling that things might have turned out differently if airway management methods were more effective in emergency settings.
“That just really struck me as something that was obviously a potential factor in the loss of my cousin, and [it instilled] a real drive to create a different future for other families of victims of accidents,” said Haggerty, the study’s first author.
The robotic device delivers a soft plastic tube into the top of the trachea. From there, the tube extends into the windpipe. Unlike current methods, the tube wends its way through the trachea by extending at its tip, mimicking the way that a vine or the end of a neuron grows.
When researchers had a trained expert test the device on a mannequin and a cadaver, the person correctly placed the tube 100% of the time. To assess whether the technology could be used by nonspecialists, they then had eight first responders test the device on cadavers. These users correctly positioned the tube on a first attempt 87% of the time and took 21 seconds on average to do so; when they used current technology, their first-pass success rate was 63% and their attempts took an average of 44 seconds.
The results, published Science Translational Medicine, come with clear caveats. The small and preliminary study does not prove whether the authors’ device would be safe and improve outcomes in live patients. But the findings lend some support to the approach, which the team hopes to test in an initial clinical study within the next year through a startup they’ve formed to commercialize the technology.
Shawn Evans, an emergency medicine specialist at Scripps Health in San Diego, said the device is well designed and that there is real need for better ways to stabilize the airways of critically injured or ill patients. But he called for a healthy dose of skepticism in interpreting the recent results.
“I remain optimistic but highly concerned about any new airway [approaches]. We’ll see what happens over time, because it’s all in the ability to reproduce what they did in simulation,” said Evans, who was not involved in the study. “That’s never as easy on a patient in the field.”
Health care providers perform around 15 million intubations every year in the United States. To do so, a doctor first uses a laryngoscope, an L-shaped instrument with a light and camera, to get a clear view of a patient’s trachea. They then push a tube past the vocal cords and into the trachea, and a ventilator pumps oxygen into the body and removes carbon dioxide from the lungs.
The common procedure can be tricky because of the complicated architecture of the airway, which evolved to keep out food and debris. A provider must carefully work the laryngoscope through the back of a patient’s mouth, down, forward, and then down again to lift open a little flap of cartilage at the top of the trachea known as the epiglottis.
Doing this quickly and correctly when a patient’s life is on the line can be a struggle. Emergency intubations performed before a patient arrives in the hospital fail 35% of the time on a first attempt, compared to 3% to 15% in the operating room.
The authors’ device consists of two parts: a plastic introducer, which a user guides into a patient’s mouth, and an endotracheal tube. The tube differs from standard designs, Haggerty said, both in its unusual softness and in how it extends into the trachea. While the current approach is to push the entirety of the tube along into the airway, the team’s device extends only at the tip. The authors argue that this approach should reduce the stress the endotracheal tube places on the airway, and they found that it reduced the force applied on a 3D-printed model of the larynx.
The eight first responders who tested the device, including four paramedics and four emergency medical technicians, became adept at using the instrument after five minutes of training. Haggerty said that bodes well for subsequent studies in real-world settings.
“My level of confidence that these gains that we’ve shown in this paper are going to have meaningful clinical impact is very high, because I think that we were able to show these significant differences even in the most controlled setting, and the settings only get more complicated from here on out,” Haggerty said.
Evans, however, is less sure. He noted that other groups have touted the potential of various new approaches over the years that have shown stellar results in preliminary testing only to underperform in clinical studies. Part of the issue, he said, is that it is difficult to correctly intubate a patient without the visual aid of a laryngoscope in an emergency, adding that patients often have vomit or other debris blocking their airways.
“I wouldn’t condemn any product, but I would say that this product would have to be light years ahead of any of its ancestors” to be effective, Evans told STAT.
More definitive answers will come from planned trials. Haggerty is the CEO of Vine Medical, a startup founded in 2022 to develop the approach from him and his colleagues. The company, based in Santa Barbara, plans to conduct its first clinical test in patients getting elective surgery. Vine intends to start that study within the next six to eight months, with the primary goal of making sure the device is safe.
The company’s next step, Haggerty said, would be a randomized trial of surgical patients to show that the instrument is as safe and effective as options currently on the market. If those results are positive, the findings could help pave the way for the tool’s use in emergency settings.
