NCT02922595

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

September 21, 2016

Last Update Submit

September 25, 2019

Conditions

Intubation; Difficult

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • success rate ventilation

    60 minutes

  • time to ventilation

    180 seconds

  • time to intubation

    180 seconds

Study Arms (2)

Intubation through ILMA®

ACTIVE COMPARATOR

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®

Intubation through ILTS®

EXPERIMENTAL

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®

Interventions

Intubation through ILMA®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 ILMA®
Intubation through ILTS®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®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dpt of Anesthesiology, University of Lausanne CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35151143DERIVED

Study Officials

  • patrick Schoettker, Professor

    University Hospital Lausanne CHUV

    STUDY DIRECTOR

Central Study Contacts

Patrick Schoettker, Professor

CONTACT

+41213143030patrick.schoettker@chuv.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 21, 2016

First Posted

October 4, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

September 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)