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CTRI Number  CTRI/2025/08/093108 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On: 27/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Assessment of vocal cords 
Scientific Title of Study   Assessment of vocal cord visibility and function between Video laryngoscope vs Nasal Endoscopy in patients undergoing thyroid surgery 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohmmed Thabraze 
Designation  Post graduate 
Affiliation  Sri Manakula vinayagar medical college and hospital 
Address  Room no 109, Hospital department 1st floor, Sri Manakula vinayagar medical college and hospital, Kalitheerthalkuppam,Puducherry

Pondicherry
PONDICHERRY
605107
India 
Phone  7032641991  
Fax    
Email  mohmmedthabraze@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR.Ranjan R.V 
Designation  Professor 
Affiliation  Sri Manakula vinayagar medical college and hospital 
Address  Room no 109, Hospital department 1st floor, Sri Manakula vinayagar medical college and hospital, Kalitheerthalkuppam,Puducherry

Pondicherry
PONDICHERRY
605107
India 
Phone  7032641991  
Fax    
Email  ranjanrv2005@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mohmmed Thabraze 
Designation  Post graduate 
Affiliation  Sri Manakula vinayagar medical college and hospital 
Address  Room no 109, Hospital department 1st floor, Sri Manakula vinayagar medical college and hospital, Kalitheerthalkuppam,Puducherry

Pondicherry
PONDICHERRY
605107
India 
Phone  7032641991  
Fax    
Email  mohmmedthabraze@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Mohmmed Thabraze 
Address  No 109 Hospital first floor Department of anaesthesiology Sri manakula vinayagar medical college Kalitheerthalkuppam Puducherry 605107  
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
mohmmed thabraze  Sri manakula vinayagar medical college and hospital  Room no 109, Hospital department 1st floor, Sri Manakula vinayagar medical college and hospital, Kalitheerthalkuppam,Puducherry
Pondicherry
PONDICHERRY 
7032641991

mohmmedthabraze@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMVMCH   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nasal endoscopy  assessment of vocal cord visibility and function in thyroid surgeries  
Comparator Agent  video laryngoscope  Assessment of vocal cords visiblity and function 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age 18 to 60 years
Patient of either Gender
Patient posted for elective thyroid surgeries under ASA I II
Euthyroid
 
 
ExclusionCriteria 
Details  Patients posted for elective surgeries under ASA III
Emergency surgeries
Retro sternal extending thyroid
Anticipated difficult airway
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To check heart rate, Blood pressure, SPO2  5minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To assess patient comfort level between two groups

To note hemodynamics like Blood pressure Heart rate Mean arterial pressure & oxygen saturation of patient
 
post procedure after 5 mins  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   27/08/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Thyroid surgeries are often associated with potential complications involving the recurrent laryngeal nerve RLN injury making the assessment of vocal cord function an essential component of perioperative care  Accurate and timely identification of vocal cord mobility can significantly influence postoperative management particularly in patients at high risk of nerve injury Recurrent laryngeal nerve  integrity is checked immediately after completion of surgery and after extubation of trachea Most commonly used technique is using Macintosh laryngoscope which is known to cause patient discomfort and hemodynamic instability Other new technique like VL USG LMA C Trach Fiberoptic visualization are supported to be less stressful and reduces patient discomfort The VL provides a magnified view of the glottic structures   and is often easier to use  for practitioners with less fiberoptic experience  On the other hand the FOB remains a gold standard for airway inspection due to its flexibility and close range visualization capabilities although it requires greater expertise and may be more technically challenging when used through an SAD The use of Nasal Endoscopy to visualize the glottic structures immediately after extubation is a novel noninvasive technique of assessing vocal cord function Nasal Endoscopy provides accurate assessment of vocal fold mobility with reasonable patient comfort in the immediate post operative period Comparative studies between these modalities VL vs Nasal Endoscopy are limited particularly in the context of thyroid surgeries where precise assessment of vocal cord function is crucial This study aims Nasal to evaluate and compare the efficacy is of use and diagnostic accuracy of video laryngoscope versus Endoscopy in assessing vocal cords in patients undergoing thyroid surgery


 
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