Comparison of iLTS-D® and ILMA® for Intubation With Fiberoptic Control. Multicentric Randomised Patient-blind Study of Non-inferiority

During general anesthesia or for some life-threatening conditions (unconsciousness, respiratory insufficiency), tracheal intubation may be mandatory. Tracheal intubation consists of inserting a tube inside the trachea through the glottis, therefore allowing patients' ventilation and airway protection. However, in some cases, intubation can be difficult with standard method (e.g. direct laryngoscopy) and visualisation of the glottis may be impossible. In those cases, alternative devices may be successful (e.g. videolaryngoscopy, fiberscopy). In cases of failure of alternative devices, prioritization to patients' ventilation is mandatory and supra-glottic devices like laryngeal masks and tubes are designed to allow an adequate ventilation. These devices are present in all difficult intubations algorithms and represent a mandatory alternative. For some specific models, tracheal intubation is possible through some of the supra-glottic devices. It's the case for the ILMA, which remains, despite the fact being more than 20 years old, the Gold Standard. Until now, no other supra-glottic device equals the ILMA concerning blind intubation, which is often necessary in emergency situations or outside the operating room (e.g. out-of-hospital care).

The design and 2016 market release of a new laryngeal tube which equally allows intubation through the device (iLTS-D) and has a gastric access potentially challenges the supremacy of the ILMA. The first two studies concerning the iLTS-D have shown encouraging results. A first study made on manikins showed a similar success rate and time for intubation for the ILMA and iLTS-D, while the insertion of the LTS-D being easier and quicker than the ILMA. A second one has demonstrated a success intubation through the iLTS-D in 29 patients of 30 without any difficult intubation criteria with 2 attempts under fiberoptic control. Concerning ventilation, the iLTS-D doesn't differ of the already well-known LTS-D.