Performance of Ultrasound in the Early Diagnosis of Vocal Cords Paralysis

Thyroidectomy Clinical Trial

— PECV  

Official title:

Performance of Ultrasound in the Early Diagnosis of Vocal Cords Paralysis After Thyroidectomy or Parathyroidectomy (PECV)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03727217
• Other study ID #: RC-P0068
• Status: Completed
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: August 24, 2020

Study information

• Verified date: February 2021
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Thyroid and parathyroid surgery concerns around 50 000 patients a year in France. One of its main complications is paralysis of vocal cords, and the consequences can be serious.

In this study, the main gold is to evaluate diagnostic performances of ultrasound for an early diagnosis (as soon as awakening of the patient) of vocal cords paralysis in the post-operative period in order to prevent at best complications.

Description:

Thyroid and parathyroid surgery concerns around 50 000 patients a year in France. One of its main complications is paralysis of vocal cords. Indeed, the anatomy of the thyroid and its close location with the recurrent laryngeal nerve (responsible for the vocal cord movement) involves a possible lesion or inflammation of the nerve during the surgical procedure. This complication is common, affecting around 10% of thyroid or parathyroid patients following surgery. This complication can be reversible, with a speech therapy or a specific endoscopic treatment by an otolaryngologist.

Currently, a postoperative screening is performed by nasofibroscopy in the recovery room to directly visualize vocal cord mobility. This examination may be painful or badly tolerated by some patients.

Recent studies have highlighted the performance of ultrasound in this diagnosis. The protocol for these studies included an ultrasound distant of the intervention, while it is known that vocal cord paralysis may have earlier consequences.

In this study, the investigators would like to evaluate diagnostic performances of vocal cords ultrasound for an early diagnosis (as soon as awakening of the patient) of vocal cords paralysis in the post-operative period in order to prevent at best complications.

The main limitation of vocal cord ultrasound is mainly related to surgery. Surgery creates anatomical rearrangements, so the secondary objective of this study will be to test whether the preoperative visualization is predictive of a good postoperative visualization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: August 24, 2020
• Est. primary completion date: August 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients = 18 years

• Scheduled surgery of total or partial thyroidectomy or parathyroidectomy

• Patient been informed and given his/her written consent to participate

• Patient affiliated to a social security scheme

Exclusion Criteria:

• Patient under tutorship or curatorship

Related Conditions & MeSH terms

• Paralysis
• Paralysis of Vocal Cords
• Thyroidectomy
• Vocal Cord Paralysis

Intervention

Diagnostic Test:
• Pre and postoperative ultrasound
An ultrasound is performed in preoperative and in postoperative

Locations

Country	Name	City	State
France	Lille Catholic Hospitals	Lomme	Nord

Sponsors (2)

Lead Sponsor	Collaborator
Lille Catholic University	University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance comparison between ultrasound and nasofibroscopy	Diagnostic performances (sensitivity, specificity, positive and negative predictive value) of the immediate postoperative ultrasound (within one hour after the end of surgery), the gold standard being nasofibroscopy.	one hour after surgery
Secondary	Frequency distribution of quality of ultrasound visualization (good or bad) measured by contingency tables	Link between the good visualization of the vocal cords by preoperative ultrasound and postoperative ultrasound.	before surgery (same day), one hour after surgery
Secondary	Time for performing ultrasound		one hour after surgery