SAN FRANCISCO — Attaching a small plastic clip to endotracheal tubes, helping them conform better to airway geometry, reduced much of the throat damage typically seen after tube placement, a researcher reported here.
In a randomized clinical trial, use of the clip led to significantly lower complication rates in five of six categories, according to Andrew Vahabzadeh-Hagh, MD, of the University of California San Diego.
Reductions ranged from 29% to 76% in incidence, and the severity much less as well, he told attendees at the American Society of Anesthesiologists annual meeting.
Something like 15 million surgeries in the U.S. involve intubation each year, he said, plus another million or so in other settings such as the emergency department. Almost every patient who remains intubated for 72 hours or more develops throat pain, hoarseness, or some other problem from the procedure.
As every medical intern knows, intubation is one of the most challenging procedures as well as one of the most common. It can be difficult even for experienced clinicians. Most patients complain of pain and difficulty in talking or swallowing after the tube is removed. Sometimes the damage is severe enough to be “life-altering,” Vahabzadeh-Hagh said; tracheoesophageal fistulas are known to result.
A major reason, he explained, is that standard endotracheal tubes come with a curvature that is less pronounced than the mouth-throat-trachea geometry. At the back of laryngopharynx region, the path makes almost a 90-degree bend. Trying to slip a tube that is less sharply curved makes it almost inevitable that it will press unnaturally on airway structures.
The so-called Endo Clip is slipped onto the tracheal tube once it is in place, at the point where it needs to make that 90-degree bend. It forces the tube into a sharper bend such that it reduces pressures on the trachea.
For the randomized trial, 100 patients scheduled for outpatient surgery with endotracheal anesthesia were prospectively enrolled, assigned 1:1 to use of the clip or conventional intubation. Only patients whose procedures did not involve the head or neck were eligible. They were then surveyed the night after surgery and on days 1, 2, and 7 afterward about six types of complication:
- Mouth pain
- Throat pain
- Neck/chest pain
- Voice change
- Difficulty talking
- Difficulty swallowing
Reports at day 7 were the primary outcome.
Only voice change was not ameliorated with the clip. Mouth pain was virtually eliminated (lowered by 76%) and for several other categories the decreases in incidence exceeded 50%. The effect on throat pain was more modest, with a 29% reduction.
Effects on severity were most notable when patients were queried on days 1 and 2. By day 7, severity was much reduced in the control arm as well as among patients assigned to the Endo Clip.
No adverse effects related to the clip itself were seen. Vahabzadeh-Hagh called it “safe and easy to use.”
Next steps are unclear. Vahabzadeh-Hagh has founded a company called Larynnovation, but more studies will be needed to win marketing approval for which funding must be secured.
No commercial funding for the study was reported. Vahabzadeh-Hagh reported serving as CEO and founder of a company called Larynnovation, but he said this was not relevant to the reported work. He also reported a relationship with Hola Tec.
American Society of Anesthesiologists
Source Reference: Vahabzadeh-Hagh A, et al “A novel endotracheal tube clip to prevent post intubation laryngeal symptoms: a randomized controlled trial” ASA 2023; Abstract A1203.