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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Thyroid, Airway Morbidity

Intervention / Treatment
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* Device: CMAC Videolaryngoscope
* Device: Macintosh Laryngoscope


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraoperative nerve monitoring, airway management