Comparative Study Between Transcutaneous Ultrasonography and Direct Laryngoscopy for Assessment of Vocal Cord Mobility at the End of Thyroidectomy Operation

NCT06951295 | Completed DMC

• 1 other identifier: MS 12/2023/2024
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of work of this study is to evaluate Transcutanous Ultrasonogrphy for assessment of vocal cord mobility in comparison to Direct laryngoscopy during extubation after thyroidectomy

Conditions

Assessment of Vocal Cord Mobility; Thyroidectomy

Keywords

Thyroidectomy; Assessment of vocal cord mobility; Transcutanous ultrasonography

Outcome Measures

Primary Outcomes (1)

• Early assessment of vocal cord injury

  Early detection of any recurrant laryngeal nerve injury or paralysis at the end of surgery by vocal cords mobility examined by investigator by TLUS and by direct laryngeoscopy by anesthesiologist.

  Immediately after the surgery

Secondary Outcomes (2)

• Direct laryngoscopy adverse effects

  Perioperatively

• Transcutanous laryngeal ultrasonography

  Perioperatively

Study Arms (2)

Direct laryngoscopy

ACTIVE COMPARATOR

Direct laryngoscopy is a gold standard device to visualise the larynx and vocal cord mobility after thyroidectomy operation , that allows assessment of vocal cords mobility before extubation after thyroidectomy operation,we assess mobility with endotracheal tube and without endotracheal tube

Procedure: Thyroidectomy operation is a surgical removal of thyroid, injury of recurrent laryngeal nerve one of common complications of thyroidectomy Which can affect Vocal cords mobility

Transcutanous ultrasonography

ACTIVE COMPARATOR

Transcutanous ultrasonography is a tool non invasive reliable diagnostic method to assess vocal cords mobility , which can assess vocal cords mobility before extubation , that may be helpful to exclude recurrent laryngeal nerve injury as early as possible ,that may protect the patient from any possible complications

Procedure: Thyroidectomy operation is a surgical removal of thyroid, injury of recurrent laryngeal nerve one of common complications of thyroidectomy Which can affect Vocal cords mobility

Interventions

Thyroidectomy operation is a surgical removal of thyroid, injury of recurrent laryngeal nerve one of common complications of thyroidectomy Which can affect Vocal cords mobility PROCEDURE

Assessment of vocal cords mobility at thyroidectomy operation is very important and life saving for patient, during thyroidectomy one of common complications, injury of recurrent laryngeal nerve unilateral or bilateral, unilateral injury may complicate to dysphonia, bilateral injury may complicate to dyspnea

Also known as: Thyroidectomy, Assessment of vocal cords mobility, Recurrent laryngeal nerve injury, Thyroidectomy operation

Direct laryngoscopy; Transcutanous ultrasonography

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both sexes patients aged above 21 years
• BMI\<40kg/m2
• American Society of Anesthesiologists(ASA) Physical Status Class- II and class- III
• Scheduled for elective thyroid surgery with intact vocal cords
• Approved to give informed consent and preoperative assessment by ENT specialist using Indirect laryngoscopy.

You may not qualify if:

• Patient refused to participate.
• Morbid obesity (BMI: \>40kg/m\^2)
• Age below 21 years.
• American Society of Anesthesiologists(ASA) Physical Status Class IV.
• Previous operation in thyroid gland.
• Any previous vocal cords paralysis.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Abbassia, Egypt

Location

MeSH Terms

Interventions

Thyroidectomy

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Investigator and anesthesiologist were blinded to results in the end of surgery
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: At the same time of extubation investigator document the results and anesthesiologist record the results , they totally blind to results

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: April 30, 2025
• Study Start: January 4, 2024
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

EG (1)