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

Thyroid Clinical Trial

— LiON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02943980
• Other study ID #: JGU
• Status: Completed
• Phase: N/A
• Start date: January 3, 2017
• Est. completion date: February 15, 2019

Study information

• Verified date: May 2022
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: February 15, 2019
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Morbidity
• Thyroid
• Thyroid Diseases

Intervention

Device:
• CMAC Videolaryngoscope
In a randomised order we evaluate the quality of the IONM after securing the airway with the CMAC
• Macintosh Laryngoscope
In a randomised order we evaluate the quality of the IONM after securing the airway with the conventional Macintosh Laryngoscope

Locations

Country	Name	City	State
Germany	Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University	Mainz	Rhineland-Palatinate

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

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