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

Primary Purpose

Thyroid, Airway Morbidity

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CMAC Videolaryngoscope
Macintosh Laryngoscope
Sponsored by
Johannes Gutenberg University Mainz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid focused on measuring Intraoperative nerve monitoring, airway management

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CMAC Videolaryngoscope

Macintosh laryngoscope

Arm Description

tracheal intubation using CMAC

tracheal intubation using Macintosh laryngoscope

Outcomes

Primary Outcome Measures

Evaluation of the quality of the IONM during thyroid surgery
Evaluation of intraoperative loss of the EMG-Signal (Quality character of the IONM)

Secondary Outcome Measures

intubation success
successful tracheal intubation at the first attempt, compared to more than one attempt
Cormack and Lehane Classification
airway visualization during intubation process
Percentage of glottic opening
airway visualization during intubation process
IDS (intubation difficult score)
Summation of specific characters during the tracheal intubation

Full Information

First Posted
October 13, 2016
Last Updated
May 14, 2022
Sponsor
Johannes Gutenberg University Mainz
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1. Study Identification

Unique Protocol Identification Number
NCT02943980
Brief Title
Influenced the Type of Laryngoscopy the Intraoperative Nerve Monitoring During Thyroid Surgery
Acronym
LiON
Official Title
Influenced the Type of Laryngoscopy the Intraoperative Nerve Monitoring During Thyroid Surgery; a Controlled, Randomized Study (LiON-Study)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 3, 2017 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
February 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid, Airway Morbidity
Keywords
Intraoperative nerve monitoring, airway management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CMAC Videolaryngoscope
Arm Type
Experimental
Arm Description
tracheal intubation using CMAC
Arm Title
Macintosh laryngoscope
Arm Type
Experimental
Arm Description
tracheal intubation using Macintosh laryngoscope
Intervention Type
Device
Intervention Name(s)
CMAC Videolaryngoscope
Intervention Description
In a randomised order we evaluate the quality of the IONM after securing the airway with the CMAC
Intervention Type
Device
Intervention Name(s)
Macintosh Laryngoscope
Intervention Description
In a randomised order we evaluate the quality of the IONM after securing the airway with the conventional Macintosh Laryngoscope
Primary Outcome Measure Information:
Title
Evaluation of the quality of the IONM during thyroid surgery
Description
Evaluation of intraoperative loss of the EMG-Signal (Quality character of the IONM)
Time Frame
Quality IONM; intraoperative 1-3 hours
Secondary Outcome Measure Information:
Title
intubation success
Description
successful tracheal intubation at the first attempt, compared to more than one attempt
Time Frame
at intubation; < 120 Seconds
Title
Cormack and Lehane Classification
Description
airway visualization during intubation process
Time Frame
during the laryngoscopy; < 120 Seconds
Title
Percentage of glottic opening
Description
airway visualization during intubation process
Time Frame
during the laryngoscopy; < 120 Seconds
Title
IDS (intubation difficult score)
Description
Summation of specific characters during the tracheal intubation
Time Frame
< 120 Seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Kriege, MD
Organizational Affiliation
University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
City
Mainz
State/Province
Rhineland-Palatinate
ZIP/Postal Code
D55131
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Influenced the Type of Laryngoscopy the Intraoperative Nerve Monitoring During Thyroid Surgery

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