A new system for continuous recurrent laryngeal nerve monitoring.
Wolfram Lamadé, Christoph Ulmer, Andreas Seimer...
https://pubmed.ncbi.nlm.nih.gov/17573619/Actively Recruiting
Led by China Medical University Hospital · Updated on 2025-01-30
304
Participants Needed
1
Research Sites
N/A
Total Duration
This research investigates different techniques of intraoperative neuromonitoring IONM used during transoral endoscopic thyroidectomy vestibular approach TOETVA, a method that avoids visible scarring but carries risk of recurrent laryngeal nerve RLN injury. The study compares intermittent and continuous monitoring methods to evaluate their safety, effectiveness, and ability to detect nerve injury early during thyroid surgery. A new percutaneous continuous IONM technique using an external fixator was developed and is assessed against other methods. The study includes 304 patients who underwent TOETVA and were grouped based on the type of IONM used percutaneous continuous, peroral intermittent, or continuous monitoring. The percutaneous continuous method involves a fixed stimulation probe to continuously monitor RLN function in real time, aiming to reduce nerve injury risk. Data collected include electrode setup time, operative time, stimulation intensity, and nerve palsy rates. Participants age, sex, BMI, thyroid disease type, and operation details are recorded to compare outcomes between monitoring techniques. Researchers measure EMG signals from vocal cords, record occurrences of nerve palsy through laryngeal examination, and track electrode displacement during surgery. The study observes patients over approximately one year to assess the feasibility, safety, and effectiveness of each monitoring approach while monitoring nerve function continuously or intermittently during surgery.
CONDITIONS
Comparison of Intr-operative Neuromonitoring Technique in Trans-oral Endoscopic Thyroidectomy Vestibular Approach
Y
Yih-Huei Uen, MD
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China Medical University Hospital
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo transoral endoscopic thyroidectomy vestibular approach with intraoperative neuromonitoring techniques while surgical and immediate postoperative data are collected.
1 visit (in-person)
Duration - Up to 1 year
Participants are monitored for outcomes including nerve function and vocal cord mobility over an average of one year after surgery.
Follow-up visits as scheduled over one year
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Lead Sponsor