| CTRI Number |
CTRI/2025/08/092688 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross sectional correlational study |
| Study Design |
Other |
|
Public Title of Study
|
Studying airway using ultrasound and vocal cord grading |
|
Scientific Title of Study
|
Ultrasound guided airway assessment an observational study to correlate airway parameter to cormack-lehane grading of 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 |
Shubham Gupta |
| Designation |
Resident |
| Affiliation |
LLRM Medical College |
| Address |
LLRM Medical College,Ground floor, Room No G-12, Dept. of
Anaesthesiology LLRM Medical College, Jagrati Vihar, Meerut
Meerut
UTTAR PRADESH
250004
India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8410666206 |
| Fax |
|
| Email |
drshubhamgupta1696@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhash Dahiya |
| Designation |
Professor |
| Affiliation |
LLRM Medical College |
| Address |
102- Consultants Quarters Behind Pharmacy Department Dept. of
Anaesthesiology LLRM Medical College, Jagrati Vihar, Meerut
UTTAR PRADESH
250004
India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9837056949 |
| Fax |
|
| Email |
drsubhashllrm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubham Gupta |
| Designation |
Resident |
| Affiliation |
LLRM Medical College |
| Address |
102- Consultants Quarters Behind Pharmacy Department Dept. of
Anaesthesiology LLRM Medical College, Jagrati Vihar, Meerut
UTTAR PRADESH
250004
India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8410666206 |
| Fax |
|
| Email |
drshubhamgupta1696@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, LLRM medical college, Meerut |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology, LLRM Medical College, SVBP Hospital, Meerut, UP |
| Address |
Dept. of
Anaesthesiology LLRM Medical College, Jagrati Vihar, Meerut
UTTAR PRADESH
250004
India |
| Type of Sponsor |
Government 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 Shubham Gupta |
Sardar Vallabai Patel Hospital |
Room No. 14, Ground
floor, Beside IT Parking,
Department of
Anaesthesiology, LLRM
Medical College
Meerut
UTTAR PRADESH
Meerut
UTTAR PRADESH |
8410666206
drshubhamgupta1696@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing GA in elective non-obstetric surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patient with history of obvious cervical spine injury, restricted head movement and ankylosing spondylitis
History of artificial congenital anomaly, thyroid surgery, neck swellings, tumours
History of radiation exposure to neck or previous neck surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess correlation of distance between mucosa of tongue from skin measured by ultrasound to cormack lehane grading |
Assessed during time of laryngoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess correlation of distance between mucosa of tongue from skin measured by ultrasound to mallapati grading |
Assessed during time of laryngoscopy |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
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)
|
20/08/2025 |
| 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="0"
Months="8"
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
|
Our study intends to find an observable definite end points for measurement to reduce variability. We also simplified the protocol so that it can be applied in a short time. In this regard a simple measurement of depth of base of tongue as in our study is equally effective in predicting difficult airway. Because of simplicity this assessment can be done during PAC on routine basis. Anaesthesia trainees also can be trained. |