Airway Morbidity, Thyroid
Conditions
Keywords
Intraoperative nerve monitoring, airway management
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.
Interventions
DEVICECMAC Videolaryngoscope
In a randomised order we evaluate the quality of the IONM after securing the airway with the CMAC
DEVICEMacintosh Laryngoscope
In a randomised order we evaluate the quality of the IONM after securing the airway with the conventional Macintosh Laryngoscope
Sponsors
Johannes Gutenberg University Mainz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed