| 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
|
|
|
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
|
|
|
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
|
|
|
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 |