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

NCT ID: NCT02922595

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-09-30

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.

Conditions

Intubation; Difficult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Intubation through ILMA®

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Intubation through ILTS®

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patrick Schoettker,MD PD

OTHER

Sponsor Role: lead

Responsible Party

Patrick Schoettker,MD PD

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

patrick Schoettker, Professor

Role: STUDY_DIRECTOR

University Hospital Lausanne CHUV

Locations

Dpt of Anesthesiology, University of Lausanne CHUV

Lausanne, Canton of Vaud, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Patrick Schoettker, Professor

Role: CONTACT

patrick.schoettker@chuv.ch

+41213143030

Facility Contacts

Patrick Schoettker, Assoc Prof

Role: primary

patrick.schoettker@chuv.ch

+41795561043

References

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.

Reference Type: DERIVED

PMID: 35151143 (View on PubMed)

Other Identifiers

2016-00902

Identifier Type: -

Identifier Source: org_study_id