Pre-clinical study

A pre-clinical study on a Fix4Life human body cadaver was conducted. This investigation involved simulating airway leakage when using a Supraglottic Airway Device. The study revealed that applying external pressure on the airway can modify internal anatomy, reducing airway leakage.

Literature study

A systematic review of the literature was conducted, revealing an incidence of oropharyngeal air leakage of supraglottic airway devices (SADs) of 5% – 52%. This wide range could be caused by: (1) numerous different factors that can cause air leakage; (2) varying definitions for air leakage; and (3) the different methods used to detect air leakage.

A study for pre-hospital airway management revealed that 25.61% reported minimal SAD leaks, and 8.46% reported major leaks. Another study reported a rate of 18.3%. A total of 53% of ambulance calls needing advanced airway management are due to out-of-hospital cardiac arrest. The use of SAD instead of tracheal intubation is different across countries but is generally seen to have increased preference over the years.

Clinical study

Tests in practice involved five anesthesiologists to measure the pusher fit, providing them with two sizes to choose from. From this test, it was concluded that one pusher size is sufficient to be used on all adult patients. In addition, one anesthesiologist reported that 9 out of 10 leakages were solved by LarynxLock.

LarynxLock performance was tested using a prototype. The test was done in a total of 79 patients using different SAD types (Classic and I-gel). Based on an observation of leakage volume in 76 cases, LarynxLock successfully solved the leakage in all patients (100%). This was consistent across different patient profiles (male and female), including those with missing teeth and with a BMI of 30 and above (classified as obese).

Usability questionnaire

A post-procedure questionnaire asking three anesthesia assistants confirmed that LarynxLock solved leakages, has a practical design, and would recommend it to colleagues. It was also demonstrated that LarynxLock reliably stayed in place throughout the procedure and did not interfere or obstruct other devices.