Performance of Ultrasound in the Early Diagnosis of Vocal Cords Paralysis (PECV)

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

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.

Study Overview

• Status: Completed
• Conditions: Thyroidectomy; Paralysis of Vocal Cords
• Intervention / Treatment: Diagnostic test: Pre and postoperative ultrasound

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nord
    • Lomme, Nord, France, 59462
      • Lille Catholic Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre and postoperative ultrasound; An ultrasound is performed in preoperative and in postoperative.	Diagnostic test: Pre and postoperative ultrasound; An ultrasound is performed in preoperative and in postoperative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time for performing ultrasound		one hour after surgery

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Collaborators: University Hospital, Lille
• Investigators: Principal Investigator: Claire Texier, Dr, Lille Catholic University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2018
• Primary Completion (Actual): August 24, 2020
• Study Completion (Actual): August 24, 2020

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Ultrasound; Thyroidectomy; Paralysis of Vocal Cords
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Cranial Nerve Diseases; Laryngeal Diseases; Vagus Nerve Diseases; Paralysis; Vocal Cord Paralysis
• Other Study ID Numbers: RC-P0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No