Elective Surgery Requiring Tracheal Intubation Using an Oral Tracheal Tube Clinical Trial
The disposable Air-Q self-inflating laryngeal intubation mask (Air-Q, Mercury Medical,
Clearwater, FL, USA) is an extra-glottic airway device which enables blind intubation with a
tracheal tube. This intubating laryngeal airway device (ILA) is already commercially
available and worldwide certificated (CE 0482), but data about the success rates of blind
intubation via this device in adult patients are lacking. Success rates of blind intubations
with the non-self-inflating device range between 57 and 97%.
Although the self-inflating disposable Air-Q device is certified for blind intubation, the
success rate and rate of adverse events associated with this procedure have not been
published so far. In a study comparing adverse events of conventional intubation with blind
intubation via a different supra-glottic airway device (ILMA) the rates of sore throat and
cough were comparable in both groups and were reported in 10-17% of the patients. In a pilot
study using the non-self-inflating Air-Q for blind intubation in 19 patients, 10% reported
dysphagia and one patient had a bilateral lingual nerve injury which was self-limited. One
study using the self-pressurised disposable Air-Q for ventilation of children showed
broncho- or laryngospasm in 3% and mucosal damage such as blood stained ILA or sore throat
were reported in 1%.
This data suggests that the rate of adverse events using the Air-Q supra-glottic device are
comparable to other devices such as LMA.
- Trial with medical device
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment