| CTRI Number |
CTRI/2025/11/097543 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Using Ultrasound Before Surgery to Predict unanticipated difficult airway and comparing USG with CL grade |
|
Scientific Title of Study
|
PREOPERATIVE AIRWAY ULTRASONOGRAPHY AS PREDICTOR FOR DIFFICULT AIRWAY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uday Partap Singh Josan |
| Designation |
Junior resident |
| Affiliation |
Maharishi Markandeswar Medical College and Hospital |
| Address |
Department of Anaesthesia Third floor Maharishi Markandeswar Medical College and Hospital village Kumarhatti Solan
Himachal Pradesh
173229
India
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8054881150 |
| Fax |
|
| Email |
udayjosan0797@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smriti Anand |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeswar Medical College and Hospital |
| Address |
Department of Anaesthesia Third floor Maharishi Markandeswar Medical College and Hospital village Kumarhatti Solan
Himachal Pradesh
173229
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
9418079103 |
| Fax |
|
| Email |
Gupta.smriti1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smriti Anand |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeswar Medical College and Hospital |
| Address |
Department of Anaesthesia Third floor Maharishi Markandeswar Medical College and Hospital village Kumarhatti Solan
Himachal Pradesh
173229
HIMACHAL PRADESH
173229
India |
| Phone |
9418079103 |
| Fax |
|
| Email |
Gupta.smriti1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Uday Partap Singh |
| Address |
MMMCH KUMARHATTI SOLAN (HP)
India
Pincode 173229 |
| 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 Uday Partap Singh |
MMMCH |
KUMARHATTI SOLAN, HP
Solan
HIMACHAL PRADESH |
8054881150
udayjosan0797@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC/MMMCH |
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 |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients aged 18 years and above, classified as ASA physical status I–III, scheduled for elective surgeries under general anesthesia, will be evaluated preoperatively. Written informed consent will be obtained from all participants. Exclusion criteria include known difficult airway requiring awake intubation, facial or neck deformities, emergency surgeries, or refusal to consent. Standard demographic and clinical data, including age, sex, BMI, comorbidities, and previous anesthesia history, will be recorded. Conventional airway assessments (Mallampati score, thyromental distance, inter-incisor distance, neck mobility) will be performed. In addition, preoperative airway ultrasonography will measure key anatomical parameters such as tongue thickness, anterior neck soft tissue, and distance from skin to epiglottis. These ultrasound findings will be correlated with laryngoscopic view and intubation difficulty (Cormack-Lehane grade) to assess whether ultrasonography improves prediction of difficult airway compared to standard clinical assessment.
|
|
| ExclusionCriteria |
| Details |
Patients with expected difficult airway
Previously confirmed difficult airway
MPG 3 & 4
ASA 4
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find unanticipated difficult airway using USG of airway |
Pre op day before surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nll |
Nil |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
25/11/2025 |
| 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="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
|
This study aims to evaluate the utility of preoperative airway ultrasonography in predicting difficult airway in adult patients undergoing elective surgery under general anesthesia. Ultrasound measurements of airway structures—including tongue thickness, anterior neck soft tissue, and distance from skin to epiglottis—will be performed preoperatively and correlated with conventional airway assessment scores and laryngoscopic view during intubation. The study seeks to determine whether ultrasound parameters improve the accuracy of difficult airway prediction compared to standard clinical assessment.
|