Influenced the Type of Laryngoscopy the Intraoperative Nerve Monitoring During Thyroid Surgery (LiON)

May 14, 2022 updated by: Marc Kriege, MD, Johannes Gutenberg University Mainz

Influenced the Type of Laryngoscopy the Intraoperative Nerve Monitoring During Thyroid Surgery; a Controlled, Randomized Study (LiON-Study)

A randomized controlled prospective study of laryngoscopy and evaluation of the Intraoperative nerve monitoring during thyroid surgery comparing direct laryngoscopy and the C-MAC videolaryngoscope.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intraoperative nerve monitoring (IONM) is used in addition to the visual the nerve in thyroid surgery. Here, the IONM can be done by placing electrodes on an endotracheal tube. In order to guarantee a sufficient signal quality of the IONM, the electrode must be adequately positioned on the glottis. The present study pursued the question of whether the conventional direct laryngoscopy compared with video laryngoscopy allows a visually adequate tube placement.

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, D55131
        • Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 Years No concurrent participation in another study
  • capacity to consent
  • Present written informed consent of the research participant
  • Elective surgery under general anesthesia

Exclusion Criteria:

  • Age <18 years
  • Existing pregnancy
  • Lack of consent
  • inability to consent
  • emergency patients
  • Emergency situations in the context of a Difficult Airway Management
  • ASA classification 4
  • situations where the possibility of accumulated gastric contents
  • Participation in another study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CMAC Videolaryngoscope
tracheal intubation using CMAC
Device: CMAC Videolaryngoscope
In a randomised order we evaluate the quality of the IONM after securing the airway with the CMAC
Experimental: Macintosh laryngoscope
tracheal intubation using Macintosh laryngoscope
Device: Macintosh Laryngoscope
In a randomised order we evaluate the quality of the IONM after securing the airway with the conventional Macintosh Laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the quality of the IONM during thyroid surgery
Time Frame: Quality IONM; intraoperative 1-3 hours
Evaluation of intraoperative loss of the EMG-Signal (Quality character of the IONM)
Quality IONM; intraoperative 1-3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intubation success
Time Frame: at intubation; < 120 Seconds
successful tracheal intubation at the first attempt, compared to more than one attempt
at intubation; < 120 Seconds
Cormack and Lehane Classification
Time Frame: during the laryngoscopy; < 120 Seconds
airway visualization during intubation process
during the laryngoscopy; < 120 Seconds
Percentage of glottic opening
Time Frame: during the laryngoscopy; < 120 Seconds
airway visualization during intubation process
during the laryngoscopy; < 120 Seconds
IDS (intubation difficult score)
Time Frame: < 120 Seconds
Summation of specific characters during the tracheal intubation
< 120 Seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Investigators

  • Principal Investigator: Marc Kriege, MD, University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2017

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

February 15, 2019

Study Registration Dates

First Submitted

October 13, 2016

First Submitted That Met QC Criteria

October 23, 2016

First Posted (Estimate)

October 25, 2016

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 14, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JGU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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