Electrophysiologic Study of Perioperative Monitoring of the Recurrent Laryngeal Nerve: Impaired Vocal Cord Movement After Thyroidectomy

Recurrent Laryngeal Nerve Clinical Trial

— NERLICORDE  

Official title:

Electrophysiologic Study of Perioperative Monitoring of the Recurrent Laryngeal Nerve: Impaired Vocal Cord Movement After Thyroidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02886481
• Other study ID #: PI2013_843_0013
• Status: Completed
• Phase: N/A
• First received: August 29, 2016
• Last updated: November 29, 2016
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: November 2016
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial Summary

Paralysis of the recurrent (or inferior) laryngeal nerve (RLN or ILN) is one of the most common and most serious complications of thyroid surgery. Neuromonitoring of the inferior laryngeal nerve (ILN or recurrent) is a technique currently used during thyroidectomy to locate ILN during dissection. Detector electrodes are placed in contact with vocal muscle which is stimulated electrically at the location of ILN, producing an acoustic and visual signal. This is a basic electromyographic technique whose diagnostic and prognostic potential for the entire neuromuscular system has not yet been fully explored. The study of action potentials generated by the stimulation-detection of nerves ILN and vagal nerves at the beginning and end of dissection, notably the decrease in amplitude, could allow a diagnosis during the course of surgery making it possible to diagnose lesions of the nerve and guide the surgeon in his surgical decisions, thus avoiding the risk of bilateral recurrent paralysis. It could also enable the surgeon to give a prognosis for functional recovery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing a total thyroidectomy or a thyroid lobectomy

Exclusion Criteria:

• History of mobility disorder of the vocal cords

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Recurrent Laryngeal Nerve

Intervention

Device:
• perioperative monitoring

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	CHU Nimes	Nimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	electrophysiologic state of the inferior laryngeal nerve	To study electrophysiologic state of the inferior laryngeal nerve with a neurostimulator during thyroidectomies in order to validate its diagnostic usefulness for ILN impairment of vocal cord movement.	Day 1	No