An interventional study of Transcartilage needle electrode recording and Endotracheal tube surface electrode recording in Thyroid Diseases, Recurrent Laryngeal Nerve Injury and Vocal Cord Paralysis, sponsored by Marmara University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Marmara University · Not applicable, Interventional, and Diagnostic
Intraoperative neuromonitoring of the recurrent laryngeal nerve during thyroidectomy is most commonly performed with surface electrodes embedded in the endotracheal tube (ETT). ETT electrodes are prone to malposition, rotation and secretions, which can produce low signal amplitudes and false signal loss. Transcartilage needle electrodes (TCN), placed into the thyroid cartilage, have been reported to yield higher and more stable amplitudes. This single-center prospective study records ETT and TCN signals simultaneously in the same patient during thyroidectomy, so that each patient serves as their own control. The primary aim is to compare how often each electrode type shows a false amplitude decrease of more than 50% in nerves without true injury. Voice and swallowing outcomes are assessed before surgery and at 2 weeks and 3 months after surgery using the Turkish versions of the Voice Handicap Index-10 and the Eating Assessment Tool-10.
Patients scheduled for primary total thyroidectomy or hemithyroidectomy are enrolled consecutively at a single center. All operations are performed by experienced endocrine surgeons using a standardized capsular dissection technique. After induction, a neuromonitoring endotracheal tube with surface electrodes is positioned by the anesthetist. At the start of the operation, after the skin incision and exposure of the thyroid cartilage, paired needle electrodes are inserted into the anterior thyroid cartilage in the subperichondrial plane. Both electrode channels are connected to the same neuromonitoring system and record simultaneously throughout the procedure. Electromyographic responses are obtained according to the standard V1, R1, R2, V2 algorithm: vagal stimulation before dissection (V1), recurrent laryngeal nerve stimulation after identification (R1), recurrent laryngeal nerve stimulation after completion of lobar dissection (R2) and vagal stimulation at the end of the procedure (V2). Amplitude and latency are recorded from both channels at each step. Loss of signal is defined according to the International Neural Monitoring Study Group criteria. When loss of signal occurs, the standard troubleshooting algorithm is applied and the operative strategy is adjusted accordingly. True nerve injury is determined from the combination of the loss-of-signal algorithm, intraoperative findings and postoperative vocal cord examination within 2 weeks after surgery, which is performed in patients with voice symptoms and in all patients in whom loss of signal was recorded. Voice and swallowing are assessed with the Turkish versions of the Voice Handicap Index-10 and the Eating Assessment Tool-10 before surgery and at 2 weeks and 3 months after surgery. The primary analysis uses one nerve per patient, on the first side evaluated. The two electrode types are compared within the same nerve using the two-sided exact McNemar test.
207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.
This study's planned enrollment of 100 is above the median of 75 across 121 interventional studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
Compared within Thyroid Nodule, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Thyroid Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The criteria were revised on the registry on Oct 30, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants undergo thyroidectomy with simultaneous recording from an endotracheal tube surface electrode and transcartilage needle electrodes. Each participant serves as their own control.
Device: Transcartilage needle electrode recording · Device: Endotracheal tube surface electrode recording
Paired needle electrodes are inserted into the anterior thyroid cartilage in the subperichondrial plane through the existing neck incision at the start of the operation, and removed at the end. Electromyographic responses to vagal and recurrent laryngeal nerve stimulation are recorded at vagal stimulation before dissection (V1), recurrent laryngeal nerve stimulation after identification (R1), recurrent laryngeal nerve stimulation after completion of lobar dissection (R2) and vagal stimulation at the end of the procedure (V2).
A standard neuromonitoring endotracheal tube with surface electrodes is positioned at intubation. Electromyographic responses to vagal and recurrent laryngeal nerve stimulation are recorded at the same four stimulation steps, simultaneously with the needle electrode channel.
Rate of false amplitude decrease greater than 50%
Proportion of evaluations in which the amplitude at vagal stimulation after resection (V2) is more than 50% lower than the amplitude at vagal stimulation before resection (V1), among nerves in which no true nerve injury is present. One nerve per patient is analyzed, on the first side evaluated, and the two electrode types are compared within the same nerve using the two-sided exact McNemar test. True nerve injury is determined by a combination of a standard loss-of-signal algorithm, intraoperative findings and, where indicated, postoperative laryngoscopy performed within 2 weeks after surgery.
Time frame: Intraoperative recording (up to 4 hours), with true nerve injury status ascertained by postoperative laryngoscopy within 2 weeks after surgery
Proportion of evaluations with a baseline amplitude of 500 microvolts or more at vagal stimulation before resection (V1)
Time frame: Intraoperative, before resection (up to 2 hours)
Proportion of evaluations in which the final amplitude is unchanged or higher than baseline
Time frame: Intraoperative, up to 4 hours
Signal amplitude in microvolts at each stimulation step
Amplitude recorded at vagal stimulation before dissection (V1), recurrent laryngeal nerve stimulation after identification (R1), recurrent laryngeal nerve stimulation after completion of lobar dissection (R2) and vagal stimulation at the end of the procedure (V2).
Time frame: Intraoperative, up to 4 hours
Signal latency in milliseconds at each stimulation step
Latency recorded at vagal stimulation before dissection (V1), recurrent laryngeal nerve stimulation after identification (R1), recurrent laryngeal nerve stimulation after completion of lobar dissection (R2) and vagal stimulation at the end of the procedure (V2).
Time frame: Intraoperative, up to 4 hours
Rate of technical failure, defined as failure to obtain a baseline signal
Time frame: Intraoperative, before resection (up to 2 hours)
Positive and negative predictive value of each electrode type for true nerve injury
Time frame: From surgery to 3 months after surgery
Change in Turkish Voice Handicap Index-10 total score
The Turkish version of the Voice Handicap Index-10 (VHI-10) is a 10-item patient-reported questionnaire on voice-related handicap. Each item is scored from 0 to 4, giving a total score from 0 (best) to 40 (worst). Higher scores indicate greater voice handicap, so an increase from baseline is a worse outcome.
Time frame: Baseline, 2 weeks and 3 months after surgery
Change in Turkish Eating Assessment Tool-10 total score
The Turkish version of the Eating Assessment Tool-10 (EAT-10) is a 10-item patient-reported questionnaire on swallowing difficulty. Each item is scored from 0 to 4, giving a total score from 0 (best) to 40 (worst). Higher scores indicate greater swallowing difficulty, so an increase from baseline is a worse outcome.
Time frame: Baseline, 2 weeks and 3 months after surgery
Incidence of adverse events attributed to electrode placement
Time frame: From surgery to 3 months after surgery
Plan to share: No — Individual participant data are not planned to be shared.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jul 2027, 8 months later.
Of 67 non-industry interventional studies with no phase under Thyroid Nodule, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 46. This study's planned 8 months is below that.
Counting every sponsor, half of 71 studies reached it within 30 months; a quarter within 14 and three quarters within 46.
Primary completion moved once since we started tracking on Sep 25, 2026: Jun 2027 → Jul 2027, on Oct 30, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.