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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02922595
Other study ID # 2016-00902
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date September 2019

Study information

Verified date September 2019
Source University of Lausanne Hospitals
Contact Patrick Schoettker, Professor
Phone +41213143030
Email patrick.schoettker@chuv.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 198
Est. completion date September 2019
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Switzerland Dpt of Anesthesiology, University of Lausanne CHUV Lausanne VD

Sponsors (1)

Lead Sponsor Collaborator
Patrick Schoettker,MD PD

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary time necessary to intubate We will measure the time necessary to intubate 180 seconds
Secondary success rate ventilation Secondary endpoint will be success rate for ventilation for both devices 60 minutes
Secondary time to ventilation Secondary endpoint will be time necessary to achieve for ventilation for both devices 180 seconds
Secondary time to intubation Secondary endpoint will be time necessary for intubation for both devices 180 seconds
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