| CTRI Number |
CTRI/2025/11/096746 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study on adult patient undergoing elective surgery under general anaesthesia to evaluate ultrasound measurement of tounge thickness as a predictor of difficult airway management |
|
Scientific Title of Study
|
Evaluation of ultrasound based assessment of tongue thickness as a predictor of difficult 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 Neeharika Arora |
| Designation |
professor |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
RoomNo2062-D,DepartmentofAnaesthesia,RohilkhandMedical College and Hospital, Pilibhit bypass road, Bareilly
Bareilly
UTTARPRADESH 243006
India
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8077104070 |
| Fax |
|
| Email |
docneehars@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeharika Arora |
| Designation |
professor |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
RoomNo2062-D,DepartmentofAnaesthesia,RohilkhandMedical College and Hospital, Pilibhit bypass road, Bareilly
Bareilly
UTTARPRADESH 243006
India
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8077104070 |
| Fax |
|
| Email |
docneehars@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tazakiyah Jahan |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
RoomNo2062-D,DepartmentofAnaesthesia,RohilkhandMedical College and Hospital, Pilibhit bypass road, Bareilly
Bareilly
UTTARPRADESH 243006
India
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8789117935 |
| Fax |
|
| Email |
jahantazakiyah98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College and Hospital Philibhit bypass road Bareilly
UTTAR PRADESH INDIA
243006 |
|
|
Primary Sponsor
|
| Name |
RohilkhandMedicalCollegeandHospital |
| Address |
Rohilkhand Medical College and Hospital Pilibhit bypass road Bareilly Uttar pradesh INDIA 243006 |
| 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 Neeharika Arora |
Rohilkhand Medical College and Hospital Bareilly |
Dept of anaesthesiology and operation theater,Rohilkhand Medical College and Hospital Philibhit bypass road Bareilly 243006
Bareilly
UTTAR PRADESH
Bareilly
UTTAR PRADESH |
8077104070
docneehars@gmail.co |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE RMCH BAREILLY U P |
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 |
| Comparator Agent |
Direct laryngoscopy grading |
Cormack–Lehane grading during first laryngoscopy attempt is used as the reference standard to classify difficult vs easy laryngoscopy. |
| Intervention |
Ultrasound based tongue thickness assessment |
A non invasive ultrasound scan of the tongue is performed in supine position before anaesthesia to measure tongue thickness |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1Patients posted for elective surgeries requiring endotracheal intubation
2American Society of Anesthesiologists ASA physical status classification I or II
|
|
| ExclusionCriteria |
| Details |
1.patient undergoing for emergency surgery 2.Maxillofacial deformities or history of facial trauma.
3.Documented history of difficult intubation.
4.BMI more then 30 kilogram per meter square
5.Patients with cervical spine injury.
6.Patients unwilling to participate.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the ultrasound based tounge thickness as a predictor of difficult laryngoscopy |
Preoperative 3 readings will be taken and out of which average will be calculated at baseline 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the predictive accuracy of ultrasound-measured tongue thickness with conventional airway assessment parameters such as Modified Mallampati score & intubation difficulty score |
12 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
11/11/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study aims to determine whether ultrasound measurement of tongue thickness can accurately predict difficult laryngoscopy in adult patients undergoing elective surgery under general anaesthesia A Laryngoscopy will be performed by an anaesthesiologist blinded to ultrasound findings and laryngoscopic view will be graded using the Cormack Lehane classification along with the Intubation Difficulty Scale The diagnostic accuracy of tongue thickness will be compared against conventional clinical predictors such as Mallampati score thyromental distance and neck circumference The study seeks to establish tongue thickness as a simple non invasive and reproducible tool for early identification of patients at risk of difficult airway management |