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

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 Overview

• Status: Enrolling by invitation
• Conditions: Parathyroidectomy; Thyroid Surgeries
• Intervention / Treatment: Device: intraoperative neuromonitoring with transcartilaginous needle electrodes versus endotracheal tube electrodes in thyroid and parathyroid surgery

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece
    • 2nd Surgical Department of Aristotle University of Thessaloniki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Active Comparator: Endocrine surgery patients; 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

Device: intraoperative neuromonitoring with transcartilaginous needle electrodes versus endotracheal tube electrodes in thyroid and parathyroid surgery; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
positive predictive value	during surgery

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Investigators: Study Chair: Stefanos Atmatzidis, Assistant Professor of Surgery, 2nd Surgical Department of Aristotle University of Thessaloniki

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: parathyroid surgery; thyroid surgery; intraoperative neuromonitoring; endocrine surgery; transcartilaginous needle electrodes; endotracheal tube electrodes
• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Monitoring, Physiologic; Monitoring, Intraoperative; Neurophysiological Monitoring; Intraoperative Neurophysiological Monitoring
• Other Study ID Numbers: 5402-2207-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Any Individual Participant's Data could be shared upon request (not including personal data)
• IPD Sharing Time Frame: The start date is from enrollment date and end date until study completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No