NCT04986592|Completed
Predisection Risk Factors for Vocal Cord Palsy After Total Thyroid Surgery
Recurrent Laryngeal Nerve Monitoring for the Assessment of the Vocal Cords in Thyroid Surgery
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Recurrent Laryngeal Nerve Monitoring for the Assessment of the Vocal Cords in Thyroid Surgery
Sponsor study identifier
observational
106
0 countries
N/A
Study Start
April 2014
Actual (reported)Primary Completion
May 2015
Actual (reported)Study Completion
December 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2014
Actual (reported)May 2015
Actual (reported)December 2015
Actual (reported)June 16, 2021
Actual (reported)August 3, 2021
Actual (reported)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
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.
Enric Caubet
Hospital Vall d'Hebron , Barcelona. Spain
Marcos De Miguel
Hospital Vall d'Hebron , Barcelona. Spain
Oscar González
Hospital Vall d'Hebron , Barcelona. Spain
Mercedes Velasco, Ph
Hospital Universitari Vall d'Hebron Research Institute
106 participants (actual enrollment reported by the registry).
First Submitted
June 16, 2021
First Posted
August 3, 2021
Study Start
April 2014
Actual (reported)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.
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Miriam De Nadal
Hospital Vall d'Hebron , Barcelona. Spain
Eva Pelaez
Hospital Vall d'Hebron , Barcelona. Spain
Primary Completion
May 2015
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
August 5, 2021
Record last verified: 2021-08
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