Transcutaneous Laryngeal Ultrasound as an Alternative to Direct Flexible Laryngoscopy in Assessment of Vocal Cords

December 5, 2023 updated by: Walaa Mohamed Ali sayd, Assiut University

Transcutaneous Laryngeal Ultrasoungraphy (TLUS) as an Alternative to Direct Flexible Laryngoscopy (DFL) in Assessment of Vocal Cords Appearance in Patients Underwent Thyroid Surgery

To evaluate the diagnostic value of ultrasound in the assessment of the vocal cords compared with direct flexible laryngoscopy

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Thyroid and parathyroid surgery are the most common procedures in endocrine surgery worldwide. They are mainly associated with two major complications: recurrent laryngeal nerve (RLN) palsy and hypoparathyroidism, The preservation of recurrent laryngeal nerve (RLN) is an essential part of thyroid surgery {1}. The various methods to test the normal functionality of vocal cords (VCs) include direct visualisation under the fiber bronchoscope, indirect laryngoscopy, laryngeal muscles electromyography, computed tomography (CT), and magnetic resonance imaging (MRI). We aimed to assess the usefulness of ultrasound (USG) in the examination of VC morphology and movement.

Recurrent laryngeal nerve injury ranges from 1.4 to 5.1% following surgery involving the thyroid gland.

Otolaryngology and Head and Neck Surgery suggested that all patients undergoing thyroid and parathyroid procedures should undergo routinely preoperative and postoperative DFL [6].

Laryngoscopy is considered the golden standard to evaluate vocal fold mobility preoperatively. As it can demonstrate a paralysis of the recurrent laryngeal nerve,. Yet it is not common practice for many endocrine surgery teams because it is time consuming, imposes extra costs, and is in general, an unpleasant experience for some patients.{2} head and neck ultrasonography is a cost effective imaging tool that is currently used as an extension of patient physical examination. That is based on its safety (non invasive and non ionizing radiation dependent), repeatability, availability and good patient compliance (pain less and require no sedation). {3} recently portable ultrasound devices became widely available with dramatic improvement of the imaging quality rendering to increased diagnostic accuracy. Availability, usability and mobility of the devices encourage bedside examination which is essential in non mobile patient and ICU patient [4] .

However, the experience is limited and the reliability of the TLUS in thyroid and parathyroid surgery is still being debated

Study Type

Observational

Enrollment (Estimated)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for thyroid surgery

Description

Inclusion Criteria:

  • Patients scheduled for thyroid surgery
  • Patients underwent thyroid surgery

Exclusion Criteria:

• Patients with vocal cord paralysis because of any cause other than thyroid surgery complications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vocal cords appearance
Time Frame: Two years
Assessment of vocal cords appearance by Transcutaneous laryngeal ultrasoungraphy (TLUS) as an alternative to direct flexible laryngoscopy (DFL)
Two years
Vocal cords movement
Time Frame: Two years
Assessment of vocal cords movement by Transcutaneous laryngeal ultrasoungraphy (TLUS) as an alternative to direct flexible laryngoscopy (DFL)
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Amr Farouk, Professor, supervisor

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

December 5, 2023

First Posted (Estimated)

December 8, 2023

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • vocal cords in US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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