| CTRI Number |
CTRI/2026/02/103696 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Ultrasound Measurement and a Clinical Risk Score in Predicting Difficult Airway |
|
Scientific Title of Study
|
Comparison of Skin to Epiglottis distance measured by sonologically and El Ganzouri Risk index for Predicting Difficult laryngoscopy The prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIKHITHA K S |
| Designation |
POSTGRADUATE |
| Affiliation |
DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI, BENGALURU-560045
Bangalore
KARNATAKA
560045
India |
| Phone |
8050871282 |
| Fax |
|
| Email |
nikhitha26796@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANTOSH KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
DEPARTMENT OF ANAESTHESIOLOGY, DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI, BENGALURU-560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9845785715 |
| Fax |
|
| Email |
santman1985@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NIKHITHA K S |
| Designation |
POSTGRADUATE |
| Affiliation |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI, BENGALURU-560045
Bangalore
KARNATAKA
560045
India |
| Phone |
8050871282 |
| Fax |
|
| Email |
nikhitha26796@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, BENGALURU |
|
|
Primary Sponsor
|
| Name |
Dr Nikhitha K S |
| Address |
DEPARTMENT OF ANESTHESIOLOGY DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL BENGALURU |
| 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 |
| NIKHITHA K S |
O T COMPLEX |
DEPARTMENT OF ANAESTHESIOLOGY, DR.B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI,BENGALURU-560045
Bangalore
KARNATAKA |
08050871282
nikhitha26796@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICS COMMITTEE |
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 posted for elective surgeries needing general anesthesia.
Patient aged 18-65 years.
American society of Anesthesiology class 1 and 2 patients. |
|
| ExclusionCriteria |
| Details |
Patients with history of neck surgery, cervical spine injury, neck burn contracture.
Patients with skin lesion on anterior surface, neck swelling.
Obstetric patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Difficulty Laryngoscopy by measuring skin to epiglottis distance sonological and El-Ganzouri risk index. |
30 mins for pre anaesthetic evaluation and 15 mins to measure skin to epiglottis distance sonological and Intraoperative till intubation time. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ease of intubation and intubation time.
Mucosal trauma, lip or dental injury.
Hemodynamics response to intubation. |
Intraoperative till intubation time around 10 mins. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
22/02/2026 |
| 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="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
|
Effective airway management is essential in anaesthesiology, as difficult laryngoscopy significantly contributes to morbidity and mortality. Pre-anaesthetic airway assessment aims to identify patients at risk and plan management accordingly. The El-Ganzouri Risk Index is a validated clinical scoring system that predicts difficult intubation using parameters such as mouth opening, thyromental distance, and Mallampati grade. Ultrasound, increasingly used as a visual stethoscope, offers an objective method for airway evaluation. Measurement of skin-to-epiglottis distance by ultrasound has emerged as a potential predictor of difficult laryngoscopy. This study aims to compare the predictive value of the clinically assessed EGRI and sonologically measured SED in determining difficult laryngoscopy. |