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.
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
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.
- Conditions
- Thyroid Surgeries, Parathyroidectomy
- 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 group | Role | What they receive |
|---|---|---|
| Endocrine surgery patients | Active comparator | All 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.
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.
- First posted10 Jun 2026
- Study start1 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid SurgeriesStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evangelia Bellou, Aristotle University Of Thessaloniki
- Investigators
- Stefanos Atmatzidis, Assistant Professor of Surgery, Study chair, 2nd Surgical Department of Aristotle University of Thessaloniki
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)
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraoperative Neuromonitoring With Transcartilaginous Needle Electrodes Versus Endotracheal Tube Electrodes in Thyroid and Parathyroid Surgery
- ClinicalTrials.gov ID
- NCT07638579
- Acronym / sponsor ID
- 5402-2207-2025
- Conditions
- Thyroid Surgeries, Parathyroidectomy
- Keywords
- endocrine surgery, thyroid surgery, parathyroid surgery, transcartilaginous needle electrodes, endotracheal tube electrodes, intraoperative neuromonitoring
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 10 Jun 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.
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:
(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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endocrine surgery patients | Active comparator | Device: intraoperative neuromonitoring with transcartilaginous needle electrodes versus endotracheal tube electrodes in thyroid and parathyroid surgeryAll 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patients undergoing thyroidectomy or parathyroidectomy via cervical incision
- Signed informed consent
Key exclusion criteria (3 listed)
- Age < 18 years
- Remote access thyroidectomy or parathyroidectomy
- Presence of thyroglossal duct cyst
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 |
|---|---|---|
| intraoperative neuromonitoring with transcartilaginous needle electrodes versus endotracheal tube electrodes in thyroid and parathyroid surgeryThis 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. | Device | Endocrine surgery patients |
Primary outcome
positive predictive value
Time frame: during 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 10 Jun 2026.
- Individual participant dataSharing planned: Yes. Any Individual Participant's Data could be shared upon request (not including personal data)
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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.
Stefanos Atmatzidis, Assistant Professor of Surgery study chair
2nd Surgical Department of Aristotle University of Thessaloniki
1 site in 1 country: see every site and its status.
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.