Influenced the Type of Laryngoscopy the Intraoperative Nerve Monitoring During Thyroid Surgery; a Controlled, Randomized Study (LiON-Study)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Thyroid
- Sponsor
- Johannes Gutenberg University Mainz
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Evaluation of the quality of the IONM during thyroid surgery
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Marc Kriege, MD
MD
Johannes Gutenberg University Mainz
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
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- intubation success(at intubation; < 120 Seconds)
- Cormack and Lehane Classification(during the laryngoscopy; < 120 Seconds)
- Percentage of glottic opening(during the laryngoscopy; < 120 Seconds)
- IDS (intubation difficult score)(< 120 Seconds)