Comparison of iLTS-D® and ILMA® for Intubation With Fiberoptic Control

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intubation; Difficult

Intervention / Treatment
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* Device: Intubation through ILMA®
* Device: Intubation through ILTS®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intubation through ILMA®<br>The ILMA will be placed into patient's larynx through the mouth in accordance with manufacturer's recommendations by experienced airway providers. The Intervention will be the intubation through ILMA. We will measure the time necessary to insert it, the possibility to ventilate the patient through it and the success rate of tracheal intubation through it will be assessed. | Device: Intubation through ILMA®<br>* It will be placed into patient's larynx through the mouth in accordance with manufacturer's recommendations by experienced airway providers. Intubation will then be peformed<br>|
| Experimental: Intubation through ILTS®<br>The ILTA will be placed into patient's larynx through the mouth in accordance with manufacturer's recommendations by experienced airway providers. It will be proceeded to the intubation through ILTS and the time necessary to insert it, the possibility to ventilate the patient through it and the success rate of tracheal intubation through it will be assessed. | Device: Intubation through ILTS®<br>* It will be placed into patient's larynx through the mouth in accordance with manufacturer's recommendations by experienced airway providers. Intubation will then be peformed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate intubation | The primary endpoint will be the success rate for tracheal intubation under fiberoptic control through both devices. Intubation for patients with difficult airways is the main feature of those devices. | 60 minutes | 
| time necessary to intubate | We will measure the time necessary to intubate | 180 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate ventilation | Secondary endpoint will be success rate for ventilation for both devices | 60 minutes | 
| time to ventilation | Secondary endpoint will be time necessary to achieve for ventilation for both devices | 180 seconds | 
| time to intubation | Secondary endpoint will be time necessary for intubation for both devices | 180 seconds |