| CTRI Number |
CTRI/2025/12/099289 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
17/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prediction Of Difficult Laryngoscopy In Thyroid Surgery Patients By Combination Of Clinical And Ultrasound Guided Measurements. |
|
Scientific Title of Study
|
Prediction Of Difficult Laryngoscopy In Thyroid Surgery Patients By Combination Of Clinical And Ultrasound Guided Measurements In Terms Of Difficult View During Laryngoscopy |
| 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 Ritu Varma Jampana |
| Designation |
Post Graduate Student |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
A6, Department of Anesthesiology, Sri Ramachandra institute of higher education and research, Ramachandra Nagar, Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9789098726 |
| Fax |
|
| Email |
rituvarmaj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venkatesh S |
| Designation |
Proffesor |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
A6, Department of Anesthesiology,
Sri Ramachandra institute of higher education and research,
Ramachandra Nagar,
Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9944731220 |
| Fax |
|
| Email |
Venkymail2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venkatesh S |
| Designation |
PROFESSOR |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
A6, Department of Anesthesiology,
Sri Ramachandra institute of higher education and research,
Ramachandra Nagar,
Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9944731220 |
| Fax |
|
| Email |
Venkymail2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra institute of higher education and research, Ramachandra Nagar, Porur, Chennai-600116 |
|
|
Primary Sponsor
|
| Name |
Dr. RITU VARMA JAMPANA |
| Address |
A6, Department of Anesthesiology,
Sri Ramachandra institute of higher education and research,
Ramachandra Nagar,
Porur, Chennai-600116 |
| Type of Sponsor |
Other [Self funding ] |
|
|
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 Ritu Varma Jampana |
Sri Ramachandra institute of higher education and research |
A6, Department of Anesthesiology,
Sri Ramachandra institute of higher education and research,
Ramachandra Nagar,
Porur, Chennai-600116
Chennai
TAMIL NADU |
9789098726
rituvarmaj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Sri Ramachandra institute of higher education and research, Porur, Chennai-600116 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective thyroid surgery,
Age between 18yrs to 65 yrs,
ASA 2,
Under general anaesthesia with oral endotracheal tube. |
|
| ExclusionCriteria |
| Details |
Tracheostomy, Anaplastic or advanced cancer, Cervical spine injury or cervical disease, Pregnant patients, Atlanto-occipital extension difficulty, Patient refusal, Inability to give consent to the study, Emergency surgeries. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the predictiveness of known conventional difficulty airway predictors and ultrasound guided parameters for difficult laryngoscopy in terms of cormach lehane grading in patients with thyroid swelling for thyroid surgery. |
At baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
31/01/2026 |
| 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)
|
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
|
This prospective observational study aims to evaluate the predictiveness of known conventional difficulty airway predictors and ultrasound guided parameters for difficult laryngoscopy in terms of cormach lehane grading in patients with thyroid swelling for thyroid surgery. The ultrasound parameters are tongue thickness, pretracheal soft tissue at the level of vocal cord, skin-to-hyoid distance at the level of the vocal cords, anterior neck soft tissue thickness at the level of the vocal cords, hyomental distance, hyomental angle, skin-to-retroisthmic trachea, carotid-to-subisthmic distance. Once the patient is shifted into operation theatre, all Baseline monitors will be connected, the ultrasound parameters are measured and the followed by induction after which laryngoscopy is done and cormack lehane grade is noted. |