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

5 juni 2026 uppdaterad av: Evangelia Bellou, Aristotle University Of Thessaloniki

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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Beräknad)

300

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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

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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
positive predictive value
Tidsram: during surgery
during surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Studiestol: Stefanos Atmatzidis, Assistant Professor of Surgery, 2nd Surgical Department of Aristotle University of Thessaloniki

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 februari 2026

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

1 juni 2028

Studieregistreringsdatum

Först inskickad

5 juni 2026

Först inskickad som uppfyllde QC-kriterierna

5 juni 2026

Första postat (Faktisk)

10 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Any Individual Participant's Data could be shared upon request (not including personal data)

Tidsram för IPD-delning

The start date is from enrollment date and end date until study completion

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • ICF
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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