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

NCT07638579 | Enrolling By Invitation

• 1 other identifier: 5402-2207-2025
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Thyroid Surgeries; Parathyroidectomy

Keywords

endocrine surgery; thyroid surgery; parathyroid surgery; transcartilaginous needle electrodes; endotracheal tube electrodes; intraoperative neuromonitoring

Outcome Measures

Primary Outcomes (1)

• positive predictive value

  during surgery

Study Arms (1)

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

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

Interventions

intraoperative neuromonitoring with transcartilaginous needle electrodes versus endotracheal tube electrodes in thyroid and parathyroid surgery DEVICE

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.

Endocrine surgery patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

2nd Surgical Department of Aristotle University of Thessaloniki

Thessaloniki, Greece

Location

MeSH Terms

Interventions

Intraoperative Neurophysiological Monitoring

Intervention Hierarchy (Ancestors)

Monitoring, Intraoperative; Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Neurophysiological Monitoring; Surgical Procedures, Operative

Study Officials

• Stefanos Atmatzidis, Assistant Professor of Surgery

  2nd Surgical Department of Aristotle University of Thessaloniki

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Evangelia Bellou

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The start date is from enrollment date and end date until study completion

Locations

GR (1)