Thyroid DiseasesTRANSCOMPNCT07902349
Endotracheal Tube Versus Transcartilage Needle Electrodes for Nerve Monitoring in Thyroid Surgery
A study testing Transcartilage needle electrode recording and Endotracheal tube surface electrode recording in people with Thyroid Diseases and Recurrent Laryngeal Nerve Injury, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Diseases, Recurrent Laryngeal Nerve Injury, Vocal Cord Paralysis
- What is being tested?
- Transcartilage needle electrode recording and Endotracheal tube surface electrode recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Scheduled for primary total thyroidectomy or hemithyroidectomy
- Normal vocal cord mobility on preoperative laryngoscopic examination
- Able to read and complete the Voice Handicap Index-10 (VHI-10) and Eating Assessment Tool-10 (EAT-10) questionnaires
- Written informed consent
Who cannot join
- Preoperative vocal cord paralysis or paresis
- Previous thyroid, parathyroid or neck surgery, including completion thyroidectomy
- Previous radiotherapy to the neck
- Advanced thyroid cancer with invasion of the trachea, esophagus or larynx
- Anatomy preventing needle electrode placement, including severely calcified thyroid cartilage, previous laryngeal trauma or previous laryngeal surgery
- Neuromuscular disease such as myasthenia gravis, or other neurological disease affecting nerve conduction
Show all 12Show fewer
- American Society of Anesthesiologists (ASA) physical status 4 or higher
- Planned transoral or endoscopic approach
- Pregnancy
- Bleeding diathesis, or anticoagulant treatment that cannot be interrupted before surgery
- Concurrent neck dissection planned with thyroidectomy
- Expected inability to comply with the follow-up protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Marmara University School of Medicine Hospital, Department of General Surgery
Istanbul, 34854
Mustafa Baş, MD, +902166254545 ext. 7454, mustafa.bas@marmara.edu.tr
About this study
Official title: Comparison of Endotracheal Tube Surface Electrodes and Transcartilage Needle Electrodes for Intraoperative Neuromonitoring During Thyroidectomy: A Prospective Within-Patient Comparison
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.
Read the detailed description
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.
- Being tested
- Transcartilage needle electrode recording, Endotracheal tube surface electrode recording
- Keywords
- Intraoperative neuromonitoring, Recurrent laryngeal nerve, Thyroidectomy, Transcartilage electrode, Endotracheal tube electrode, Electromyography, Voice Handicap Index, Eating Assessment Tool
- Medical subject headings
- Thyroid Diseases, Recurrent Laryngeal Nerve Injuries, Vocal Cord Paralysis, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcartilage needle electrode recordingDevice
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).
Endotracheal tube surface electrode recordingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous dual-electrode neuromonitoring | Experimental | All participants undergo thyroidectomy with simultaneous recording from an endotracheal tube surface electrode and transcartilage needle electrodes. Each participant serves as their own control. Receives: Device: Transcartilage needle electrode recording; Device: Endotracheal tube surface electrode recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative recording (up to 4 hours), with true nerve injury status ascertained by postoperative laryngoscopy within 2 weeks after surgery
Secondary outcomes (9)
Proportion of evaluations with a baseline amplitude of 500 microvolts or more at vagal stimulation before resection (V1)
Measured: Intraoperative, before resection (up to 2 hours)
Proportion of evaluations in which the final amplitude is unchanged or higher than baseline
Measured: 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).
Measured: 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).
Measured: Intraoperative, up to 4 hours
Rate of technical failure, defined as failure to obtain a baseline signal
Measured: Intraoperative, before resection (up to 2 hours)
Positive and negative predictive value of each electrode type for true nerve injury
Measured: 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.
Measured: 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.
Measured: Baseline, 2 weeks and 3 months after surgery
Incidence of adverse events attributed to electrode placement
Measured: From surgery to 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseasesStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive both electrode types simultaneously during the same operation, so that each participant serves as their own control. There is no separate comparison group; the comparison is within-patient, between the two recording channels.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammer Ergenç, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902349
- Sponsor's protocol ID
- BES-2026-01
- Acronym
- TRANSCOMP
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endotracheal Tube Surface Electrodes and Transcartilage Needle Electrodes for Intraoperative Neuromonitoring During Thyroidectomy: A Prospective Within-Patient Comparison
- ClinicalTrials.gov ID
- NCT07902349
- Acronym / sponsor ID
- TRANSCOMP / BES-2026-01
- Keywords
- Intraoperative neuromonitoring, Recurrent laryngeal nerve, Thyroidectomy, Transcartilage electrode, Endotracheal tube electrode, Electromyography, Voice Handicap Index, Eating Assessment Tool
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive both electrode types simultaneously during the same operation, so that each participant serves as their own control. There is no separate comparison group; the comparison is within-patient, between the two recording channels.
| Arm | Type | Receives |
|---|---|---|
| Simultaneous dual-electrode neuromonitoring | Experimental | Device: Transcartilage needle electrode recording, Device: Endotracheal tube surface electrode recordingAll participants undergo thyroidectomy with simultaneous recording from an endotracheal tube surface electrode and transcartilage needle electrodes. Each participant serves as their own control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Scheduled for primary total thyroidectomy or hemithyroidectomy
- Normal vocal cord mobility on preoperative laryngoscopic examination
- Able to read and complete the Voice Handicap Index-10 (VHI-10) and Eating Assessment Tool-10 (EAT-10) questionnaires
- Written informed consent
Key exclusion criteria (12 listed)
- Preoperative vocal cord paralysis or paresis
- Previous thyroid, parathyroid or neck surgery, including completion thyroidectomy
- Previous radiotherapy to the neck
- Advanced thyroid cancer with invasion of the trachea, esophagus or larynx
- Anatomy preventing needle electrode placement, including severely calcified thyroid cartilage, previous laryngeal trauma or previous laryngeal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcartilage needle electrode recordingPaired 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). | Device | Simultaneous dual-electrode neuromonitoring |
| Endotracheal tube surface electrode recordingA 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. | Device | Simultaneous dual-electrode neuromonitoring |
Primary outcome
Rate of false amplitude decrease greater than 50%
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 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.
9 secondary outcomes
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
Time frame: Intraoperative, up to 4 hours
Signal latency in milliseconds at each stimulation step
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
Time frame: Baseline, 2 weeks and 3 months after surgery
Change in Turkish Eating Assessment Tool-10 total score
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared.
Related trials for Thyroid Diseases
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcartilage needle electrode recording and Endotracheal tube surface electrode recording in people with Thyroid Diseases and Recurrent Laryngeal Nerve Injury, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammer Ergenç, MD (+902166254545 ext. 3629, muhammer.ergenc@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of false amplitude decrease greater than 50% (time frame: Intraoperative recording (up to 4 hours), with true nerve injury status ascertained by postoperative laryngoscopy within 2 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.