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

Not Applicable

Completed

• Conditions: Thyroid; Airway Morbidity
• Interventions: Device: Macintosh Laryngoscope; Device: CMAC Videolaryngoscope

• Registration Number: NCT02943980
• Lead Sponsor: Johannes Gutenberg University Mainz

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.

Study Timeline

• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-23
• Study First Posted: 2016-10-25
• Study Start: 2017-01-03
• Primary Completion: 2018-05
• Study Completion: 2019-02-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-14
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Macintosh laryngoscope	Macintosh Laryngoscope	tracheal intubation using Macintosh laryngoscope
CMAC Videolaryngoscope	CMAC Videolaryngoscope	tracheal intubation using CMAC

Primary Outcome Measures

Name	Time	Method
Evaluation of the quality of the IONM during thyroid surgery	Quality IONM; intraoperative 1-3 hours	Evaluation of intraoperative loss of the EMG-Signal (Quality character of the IONM)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University; 🇩🇪 Mainz, Rhineland-Palatinate, Germany