Intubation; Difficult Clinical Trial
Official title:
Comparison of iLTS-D® and ILMA® for Intubation With Fiberoptic Control. Multicentric Randomised Patient-blind Study of Non-inferiority
The primary purpose of this study is to compare with a non-inferiority randomised study the new laryngeal tube (Intubating Laryngeal Tube Single-Disposable - iLTS-D) to the well-established Intubating Larygeal Mask Airway (ILMA/ Fastrach) for the success rate and time for intubation under fiberoptic control. Secondary purposes are success rates and times for ventilation for both devices and finally success rate of gastric tube placement.
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.
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