Validation Studies

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.

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) the definition of air leakage; and (3) the method that was used to detect air leakage. The study emphasized that description of the results in the most important articles were rather heterogeneous and there are many different types of SADs.

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.

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.