Clinical trial NCT02922595: Comparison of iLTS-D® and ILMA® for Intubation With Fiberoptic Control
Official title: Comparison of iLTS-D® and ILMA® for Intubation With Fiberoptic Control. Multicentric Randomised Patient-blind Study of Non-inferiority
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation; Difficult
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Adult patients who will undergo an elective surgery under general anesthesia requiring tracheal intubation
* American Society of Anesthesiology ASA Risk Class 1-3

Exclusion Criteria:

* Known difficult intubation
* Previous surgery of Ear Nose Throat (ENT)
* Symptomatic gastrooesophageal reflux
* Nauseas at time of operation
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons

Primary outcomes:
measure: success rate intubation
timeFrame: 60 minutes
measure: time necessary to intubate
timeFrame: 180 seconds
Secondary outcomes:
measure: success rate ventilation
timeFrame: 60 minutes
measure: time to ventilation
timeFrame: 180 seconds
measure: time to intubation
timeFrame: 180 seconds
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Dpt of Anesthesiology, University of Lausanne CHUV
state: VD
Study officials:
affiliation: University Hospital Lausanne CHUV
name: patrick Schoettker, Professor
role: STUDY_DIRECTOR
References:
citation: Zuercher M, Casso G, Krugel V, Potie A, Barry MP, Schoettker P. Tracheal intubation using intubating laryngeal tube iLTS-D and LMA Fastrach in 99 adult patients: A prospective multicentric randomised non-inferiority study. J Clin Anesth. 2022 Jun;78:110671. doi: 10.1016/j.jclinane.2022.110671. Epub 2022 Feb 9.