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

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.

Study Overview

• Status: Unknown
• Conditions: Intubation; Difficult
• Intervention / Treatment: Device: Intubation through ILMA®; Device: Intubation through ILTS®

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.

• Study Type: Interventional
• Enrollment (Anticipated): 198
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • VD
    • Lausanne, VD, Switzerland, 1011
      • Recruiting
      • Dpt of Anesthesiology, University of Lausanne CHUV
      • Contact: Patrick Schoettker, Assoc Prof; Phone Number: +41795561043; Email: patrick.schoettker@chuv.ch
      • Principal Investigator: Patrick Schoettker, Assoc Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intubation through ILMA®; 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®; 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
Experimental: Intubation through ILTS®; 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®; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Patrick Schoettker,MD PD
• Investigators: Study Director: patrick Schoettker, Professor, University Hospital Lausanne CHUV

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: September 21, 2016
• First Submitted That Met QC Criteria: September 30, 2016
• First Posted (Estimate): October 4, 2016

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2016-00902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO