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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03727217
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : February 3, 2021
Sponsor:
Collaborator:
University Hospital, Lille
Information provided by (Responsible Party):
Lille Catholic University

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Thyroidectomy Paralysis of Vocal Cords Diagnostic Test: Pre and postoperative ultrasound Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Performance of Ultrasound in the Early Diagnosis of Vocal Cords Paralysis After Thyroidectomy or Parathyroidectomy (PECV)
Actual Study Start Date : July 10, 2018
Actual Primary Completion Date : August 24, 2020
Actual Study Completion Date : August 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic performance comparison between ultrasound and nasofibroscopy [ Time Frame: one hour after surgery ]
    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.


Secondary Outcome Measures :
  1. Frequency distribution of quality of ultrasound visualization (good or bad) measured by contingency tables [ Time Frame: before surgery (same day), one hour after surgery ]
    Link between the good visualization of the vocal cords by preoperative ultrasound and postoperative ultrasound.

  2. Time for performing ultrasound [ Time Frame: one hour after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727217


Locations
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France
Lille Catholic Hospitals
Lomme, Nord, France, 59462
Sponsors and Collaborators
Lille Catholic University
University Hospital, Lille
Investigators
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Principal Investigator: Claire Texier, Dr Lille Catholic University
More Information
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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT03727217    
Other Study ID Numbers: RC-P0068
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lille Catholic University:
Thyroidectomy
Paralysis of Vocal Cords
Ultrasound
Additional relevant MeSH terms:
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Vocal Cord Paralysis
Paralysis
Neurologic Manifestations
Nervous System Diseases
Laryngeal Diseases
 Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Vagus Nerve Diseases
Cranial Nerve Diseases