| CTRI Number |
CTRI/2025/10/096021 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Translaryngeal (Neck) Ultrasound to Assess Vocal Cord Movement after Thyroid Surgery - Comparison with Videolaryngoscopy |
|
Scientific Title of Study
|
Diagnostic Accuracy of Translaryngeal Ultrasound Compared with Videolaryngoscopy for Assessment of Vocal Cord Movement in Post-Thyroidectomy Patients |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shah Raj Jashvantkumar |
| Designation |
Junior Resident |
| Affiliation |
Bharati Vidyapeeth deemed to be University Medical college |
| Address |
Room no 304 Third Floor Department Of Anaesthesiology
Bharati Vidyapeeth (Deemed to be University) Medical College Pune Maharashtra INDIA
Pune
MAHARASHTRA
411043
India |
| Phone |
9409561780 |
| Fax |
|
| Email |
drrajshah99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Konnur |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth deemed to be University Medical college |
| Address |
Room 304 Third Floor Department Of Anesthesiology
Bharati Vidyapeeth (Deemed to be University) Medical College Pune
Bharati Vidyapeeth Educational Campus Pune-Satara Road
Pune
MAHARASHTRA
411043
India |
| Phone |
9823890369 |
| Fax |
|
| Email |
shwetajm81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Konnur |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth deemed to be University Medical college |
| Address |
Room 304 Third Floor Department Of Anesthesiology
Bharati Vidyapeeth (Deemed to be University) Medical College Pune
Bharati Vidyapeeth Educational Campus Pune-Satara Road
MAHARASHTRA
411043
India |
| Phone |
9823890369 |
| Fax |
|
| Email |
shwetajm81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Hospital and Research Centre Pune-Satara Road, Pune-411 043, Maharashtra, INDIA |
|
|
Primary Sponsor
|
| Name |
Bharati Hospital and Research centre |
| Address |
Bharati Hospital and Research centre Pune Satara Road Pune-411 043 Maharashtra INDIA |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raj Shah Jashvantkumar |
Bharati Hospital and Research Centre |
Room 304 Third Floor Department Of Anesthesiology Bharati Hospital and Research Centre Pune Satara Road Pune 411 043 Maharashtra INDIA
Pune
MAHARASHTRA |
94095 61780
drrajshah99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed to be University Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E07||Disorders of thyroid gland, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Translaryngeal Ultrasound |
An ultrasound probe is placed externally over the anterior neck to visualize the motion of the vocal cords during phonation and respiration. This non-invasive method uses sound waves to assess vocal cord mobility without inserting any instrument into the mouth or nose. |
| Comparator Agent |
Videolaryngoscopy |
The standard reference method for assessing vocal cord movement. It involves using a flexible or rigid endoscope inserted through the mouth or nose to directly visualize and record the motion of the vocal cords. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA I II III Patients
Aged 18 years – 70 years
Patient scheduled to undergo Elective Thyroidectomy under General Anaesthesia
|
|
| ExclusionCriteria |
| Details |
Patient’s Refusing to Participate in the Study
Patients with Difficult Airway
Pre-Operative Vocal Cord Palsy/Voice Abnormalities
Previous Neck Surgeries
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accurate Assessment of Vocal Cord Movement in Post Thyroidectomy Patients |
1-2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time for Accurate Assessment of Vocal Cord Movement in Post-Thyroidectomy Patients |
1-2 hours |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Brief Summary
This study aims to evaluate the diagnostic accuracy of translaryngeal ultrasound compared with videolaryngoscopy for assessing vocal cord movement in patients after thyroidectomy. Vocal cord dysfunction due to recurrent laryngeal nerve injury is a known complication of thyroid surgery, and early detection is important to prevent airway and voice-related problems. Traditionally, videolaryngoscopy is used for assessment but it is invasive and may cause hemodynamic changes. Translaryngeal ultrasound is a simple, safe, and non-invasive alternative. In this diagnostic accuracy study, 82 adult patients undergoing elective thyroidectomy under general anaesthesia will be assessed for vocal cord movement using both techniques. The results will compare accuracy, time taken, and hemodynamic response between the two methods. The study aims to identify whether ultrasound can serve as a reliable bedside tool for postoperative vocal cord assessment. |