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Thyroid SurgeriesNCT07638579

Comparison of Intraoperative Neuromonitoring With Transcartilaginous Needle Electrodes Versus Endotracheal Tube Electrodes in Thyroid and Parathyroid Surgery

A study testing intraoperative neuromonitoring with transcartilaginous needle electrodes versus endotracheal tube electrodes in thyroid and parathyroid surgery in people with Thyroid Surgeries and Parathyroidectomy, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Injury to the recurrent laryngeal nerve (RLN) is among the most important complications in thyroid and parathyroid surgery. Intraoperative neuromonitoring (IONM) of the RLN using electrodes placed on the endotracheal tube is now a standard procedure to facilitate nerve detection and visual identification, to maintain… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Thyroid Surgeries, Parathyroidectomy
What is being tested?
intraoperative neuromonitoring with transcartilaginous needle electrodes versus endotracheal tube electrodes in thyroid and parathyroid surgery
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteGreece
Study dates
1 Feb 2026to 1 Jun 2028
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Patients undergoing thyroidectomy or parathyroidectomy via cervical incision
  • Signed informed consent

Who cannot join

  • Age < 18 years
  • Remote access thyroidectomy or parathyroidectomy
  • Presence of thyroglossal duct cyst

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Greece1 site
  • 2nd Surgical Department of Aristotle University of Thessaloniki

    Thessaloniki

Other trials in Greece

About this study

Injury to the recurrent laryngeal nerve (RLN) is among the most important complications in thyroid and parathyroid surgery. Intraoperative neuromonitoring (IONM) of the RLN using electrodes placed on the endotracheal tube is now a standard procedure to facilitate nerve detection and visual identification, to maintain its anatomical and functional integrity and to reduce the rate of nerve injuries. The most common neuromonitoring technique involves the use of electrodes located on the surface of the endotracheal tube, which are in contact with the vocal cords and record the electromyographic signals caused by the electrical stimulation of the RLN by a probe manipulated by the surgeon.

However, this technique has certain disadvantages:

Read more

(i) Correct placement of the endotracheal tube is technically demanding and requires an experienced anesthesiologist.

(ii) Improper placement of the tube by the anesthesiologist, its displacement during patient hyperextended neck positioning, intraoperative rotation, or saliva interference between the tube electrodes and the vocal cords may all lead to inability to receive adequate signals and limit the sensitivity of the method.

(iii) Intraoperative readjustment of the tube position can be time-consuming and difficult.

The above neuromonitoring method is associated with a high negative predictive value (92-100%) according to the literature. However, its positive predictive value ranges between 10% and 90% which means that in the case of a decrease or loss of the initial neurostimulation signal, the true injury of the RLN is 10-90%.

Neuromonitoring with intraoperative placement of electrodes in the thyroid cartilage is an alternative method, in which the electrodes are placed by the surgeon in the perichondrium of the thyroid cartilage at the beginning of the operation. Their placement is simple, with almost no learning curve and does not require further preparation of the surrounding structures. Similarly to the endotracheal tube electrode, these also record the electromyografic signal from the electrical stimulation of the laryngeal muscles and RLN, however they are more sensitive in detecting the movement of the vocal cords and can potentially record a higher and more stable neurostimulation signal. In this way, the rate of false positive signal loss could be reduced compared to the technique of neuromonitoring with the electrodes on the endotracheal tube.

This PhD thesis aims to evaluate the effectiveness and reliability of neuromonitoring with transcartilaginous needle electrodes versus endotracheal tube electrodes in thyroid and parathyroid surgeries. It is a prospective multicenter study of diagnostic accuracy, with paired design, of the neuromonitoring signals (amplitude - latency), which will be obtained based on the standard algorithm V1, R1, EBSLN1, EBSLN2, R2, V2, before and after the end of the manipulations in each thyroid lobe, using both aforementioned techniques. Their positive and negative predictive value will be compared and evaluated with regard to the injury of the recurrent laryngeal nerve. To achieve the above, at least 300 patients who will undergo thyroid or parathyroid gland surgery will be evaluated and intraoperatively will undergo neuromonitoring with both methods. After the surgery, on the 1st postoperative day, all patients will undergo laryngoscopy to exclude or confirm injury of the RLN.

Being tested
intraoperative neuromonitoring with transcartilaginous needle electrodes versus endotracheal tube electrodes in thyroid and parathyroid surgery
Keywords
endocrine surgery, thyroid surgery, parathyroid surgery, transcartilaginous needle electrodes, endotracheal tube electrodes, intraoperative neuromonitoring

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intraoperative neuromonitoring with transcartilaginous needle electrodes versus endotracheal tube electrodes in thyroid and parathyroid surgeryDevice

    This study aims to evaluate the effectiveness and reliability of neuromonitoring with transcartilaginous needle electrodes versus endotracheal tube electrodes in thyroid and parathyroid surgeries. It is a prospective study of diagnostic accuracy, with paired design, of the neuromonitoring signals (amplitude - latency), which will be obtained based on the standard algorithm V1, R1, EBSLN1, EBSLN2, R2, V2, before and after the end of the manipulations in each thyroid lobe, using both aforementioned techniques. Their positive and negative predictive value will be compared and evaluated with regard to the injury of the recurrent laryngeal nerve. After the surgery, on the 1st postoperative day, all patients will undergo laryngoscopy to exclude or confirm injury of the RLN.

    It is the first study that evaluates simultaneously both intraoperative neuromonitoring methods in the same patient and at such large group of patients.

Study groups in NCT07638579
Study groupRoleWhat they receive
Endocrine surgery patientsActive comparatorAll the patients submited to thyroid and/or parathyroid surgey will undergo intraoperative neuromonitoring with transcartilaginous needle electrodes and endotracheal tube electrodes at the same time
Receives: Device: intraoperative neuromonitoring with transcartilaginous needle electrodes versus endotracheal tube electrodes in thyroid and parathyroid surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. positive predictive value

    Measured: during surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start1 Feb 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

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
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07638579
Sponsor's protocol ID
5402-2207-2025
Status last verified
Jun 2026
First submitted
5 Jun 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Any Individual Participant's Data could be shared upon request (not including personal data)

Questions about this trial

What is this clinical trial studying?

A study testing intraoperative neuromonitoring with transcartilaginous needle electrodes versus endotracheal tube electrodes in thyroid and parathyroid surgery in people with Thyroid Surgeries and Parathyroidectomy, run by Aristotle University Of Thessaloniki at 1 site in Greece.

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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 10 Jun 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 Greece. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

positive predictive value (time frame: during 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 10 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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