Predisection Risk Factors for Vocal Cord Palsy After Total Thyroid Surgery

NCT04986592 | Completed

• 1 other identifier: PR AG 129/2014
• Study Type: observational
• Target: 106
• Locations: 0 countries
• Sites: N/A

Brief Summary

In patients undergoing total thyroidectomy, intraoperative nerve monitoring according to the International Standards Guideline Statement may detect nerves more susceptible to injury. The aim of our study was to evaluate the independent risk factors of vocal cord palsy, including those related to pre-dissection nerve monitoring values. Methods: Prospective observational study in 95 consecutive adult patients undergoing elective total thyroidectomy in Spain. A single experienced phonologist performed a videostroboscopy (VS) exam preoperatively and one week after surgery to assess vocal cord mobility. Each surgical procedure was performed with intermittent intraoperative neuromonitoring. Latency and amplitude values were obtained for the vagal and recurrent laryngeal nerves before surgical dissection and compared with the postoperative VS exam.

Conditions

Recurrent Laryngeal Nerve Palsy; Risk Factors of Vocal Cord Palsy; Neuromonitoring in Thyroid Surgery

Outcome Measures

Primary Outcomes (3)

• Response amplitude in recurrent laryngeal nerve in uV

  Response amplitude reflects summated EMG activity from individual muscle fibers of the thyroarytenoid. We define monitoring waveform response amplitude as the height from the vertical measurement from the apex of the positive waveform deflection to the lowest point in the opposite polarity phase of the waveform ( peak to peak). Lack of signal occurred when the monitor showed low-amplitude response waves, in electromyography response (\< 100 uV), and a high-pitched warning sound.

  Adult patients undergoing total thyroidectomy during a 12-month period

• Response amplitude in vagal nerve in uV

  Response amplitude reflects summated EMG activity from individual muscle fibers of the thyroarytenoid. We define monitoring waveform response amplitude as the height from the vertical measurement from the apex of the positive waveform deflection to the lowest point in the opposite polarity phase of the waveform ( peak to peak). Lack of signal occurred when the monitor showed low-amplitude response waves, in electromyography response (\< 100 uV), and a high-pitched warning sound.

  Adult patients undergoing total thyroidectomy during a 12-month period

• Vocal cord palsy

  Vocal cords were assessed using videostroboscopy(Laryngeal Strobe 9400, Pentax Medical, USA) by a single experienced phonologist blinded to the neuromonitoring results

  The VS exam was performed one week after surgery, through study completion, an average of 1 yearThe diagnosis of palsy (absence of motion) was made on the basis of an observation of asymmetrical laryngeal motion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive adult patients undergoing total thyroidectomy during a 12-month period. All patients understood the various aspects of the study and gave written informed consent.

You may qualify if:

• To be at least 18 years old, to accept participation in the study, and to be scheduled for a total bilateral thyroidectomy.

You may not qualify if:

• Urgent thyroidectomy, inability to perform videostroboscopy, minor patients, patient refuse to be part of the study

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

MeSH Terms

Conditions

Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Enric Caubet

  Hospital Vall d'Hebron , Barcelona. Spain

  STUDY DIRECTOR

• Marcos De Miguel

  Hospital Vall d'Hebron , Barcelona. Spain

  STUDY CHAIR

• Oscar González

  Hospital Vall d'Hebron , Barcelona. Spain

  STUDY DIRECTOR

• Mercedes Velasco, Ph

  Hospital Universitari Vall d'Hebron Research Institute

  STUDY CHAIR

• Miriam De Nadal

  Hospital Vall d'Hebron , Barcelona. Spain

  STUDY CHAIR

• Eva Pelaez

  Hospital Vall d'Hebron , Barcelona. Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: August 3, 2021
• Study Start: April 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 5, 2021

Record last verified: 2021-08