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

April 26, 2025 updated by: Ain Shams University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 thyroidectomyA. Preoperative settings: All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation and vocal cord mobility and voice quality be assessed by ENT and anesthesiologist by ultrasound.

B. Intraoperative settings:

On arrival of the patients to the operative room, electrocardiography, non-invasive blood pressure, and pulse oximetry will be applied. Baseline parameters such as heart rate (HR) , blood pressure (BP), and oxygen saturation (SpO2) will be also recorded.

Intravenous (IV) line will be inserted and IV lactated Ringer 500ml bolus then started as calculated by fluid chart. For both groups, General anesthesia will be performed After 3 minutes of pre- oxygenation, anaesthesia will be induced with IV 1 mcg/kg of fentanyl, 2 mg/kg of propofol and 0.5 mg/kg of atracurium to facilitate endotracheal intubation.

- Anesthesia will be maintained with 50% of oxygen in air, 1-2 % isoflurane and 0.1mg/kg atracurium every 20 minutes.

Both groups will receive rescue dose of fentanyl 0.5 mcg/kg for an increase in HR or MAP 20% above the baseline value. - All patients will be given IV 1 mg of granisetron and 40 mg of pantoprazole.

After end of surgery:

- Residual paralysis will be reversed with 0.05 mg/kg neostigmine and 0.02 mg/kg atropine. All patients underwent to two procedure mentioned above by two anesthesiologist.

Transcutanous ultrasonography by the investigator. Direct laryngeoscopy by the anesthesiologist. Transcutanous laryngeal ultrasonography: (TLUS) by using ultrasonogrphy sonosite 5- 10-MHz linear probe , patient 's position is supine with neck hyperextended in same position of surgery.Apply aseptic gel and sterile gloves to put probe on sutures .Probe is placed transversally on top of the thyroid cartilage to evaluate the vocal cords mobility.And move craniocaudal until two vocal cords are seen if difficult to find put probe on lateral side .True and false vocal cords will be seen, true will be hypoechoic below thyroid cartilage and false will be hyperechoic.When both true vocal cords move medially towards midline, this means NO nerve palsy.but when either one or both vocal cords not moved, this means there is nerve palsy. Direct Laryngeoscopy: Inserted in oral cavity and show both vocal cords mobility, if both mobile there is NO palsy , if one immobile and another mobile may be chance of stridor and if both immobile there is risk of airway obstruction. All results will be documented at the same time and comparison will be matched between the investigetor and the anesthesiologist and Statistical analysis will be done.

Postoperative settings: - All patients will continue to be monitored in the post- anesthesia care unit (PACU) for their HR normal range(60-100bpm), MAP normal(120/80)and SpO2> 95% on room air.

Analysis of voice change should be done by ability to speak and if there is any respiratory distress and by ENT consultation

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Egypt
    • Abbassia
      • Cairo, Abbassia, Egypt
        • Ain Shams University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Direct laryngoscopy
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
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
Other Names:
  • Thyroidectomy
  • Assessment of vocal cords mobility
  • Recurrent laryngeal nerve injury
  • Thyroidectomy operation
Active Comparator: Transcutanous ultrasonography
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
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
Other Names:
  • Thyroidectomy
  • Assessment of vocal cords mobility
  • Recurrent laryngeal nerve injury
  • Thyroidectomy operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early assessment of vocal cord injury
Time Frame: Immediately after the surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Direct laryngoscopy adverse effects
Time Frame: Perioperatively
more reliable and less adverse effects of transcutanous laryngeal ultrasonography.
Perioperatively
Transcutanous laryngeal ultrasonography
Time Frame: Perioperatively
Transcutanous laryngeal ultrasonography is comparable with direct laryngoscopy
Perioperatively

Collaborators and Investigators

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

Sponsor

Ain Shams University

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 (Actual)

January 4, 2024

Primary Completion (Actual)

January 25, 2024

Study Completion (Actual)

January 25, 2025

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

April 26, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 26, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MS 12/2023/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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