| CTRI Number |
CTRI/2025/09/094831 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ultrasound Assessment of Airway Parameters to Predict Difficult Direct Laryngoscopy in Adults Undergoing General Anaesthesia- An Observational Study |
|
Scientific Title of Study
|
Efficacy of ultrasound measured airway parameters in predicting difficult direct laryngoscopy in adult patients undergoing general anaesthesia with orotracheal intubation - an 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 |
Dr Sonal Singhal |
| Designation |
PG Resident |
| Affiliation |
Lady Hardinge Medical college |
| Address |
Department of Anaesthesia 5th floor New Academic Block Lady Hardinge Medical College Shaheed Bhagat Singh Marg DIZ Area Connaught Place New Delhi 110001
Central
DELHI
110001
India |
| Phone |
7011621466 |
| Fax |
|
| Email |
sonalradhe95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Upma Bhatia Batra |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical college |
| Address |
Department of Anaesthesia 5th floor New Academic Block Lady Hardinge Medical College Shaheed Bhagat Singh Marg DIZ Area Connaught Place New Delhi 110001
Central
DELHI
110001
India |
| Phone |
9868616048 |
| Fax |
|
| Email |
ubhatia2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Upma Bhatia Batra |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical college |
| Address |
Department of Anaesthesia 5th floor New Academic Block Lady Hardinge Medical College Shaheed Bhagat Singh Marg DIZ Area Connaught Place New Delhi 110001
DELHI
110001
India |
| Phone |
9868616048 |
| Fax |
|
| Email |
ubhatia2004@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia Lady Hardinge Medical College Shaheed Bhagat Singh Marg DIZ Area Connaught Place New Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia Lady Hardinge Medical College |
| Address |
Department of Anaesthesia 5th floor New Academic Block Lady Hardinge Medical College Shaheed Bhagat Singh Marg DIZ Area Connaught Place New Delhi 110001 |
| 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 Sonal Singhal |
Lady Hardinge Medical college |
Department of Anaesthesia 5th floor New Academic Block Lady Hardinge Medical College Shaheed Bhagat Singh Marg DIZ Area Connaught Place New Delhi 110001
Central
DELHI |
07011621466
sonalradhe95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee for human research LHMC and associated hospitals,New Delhi |
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 |
Ultrasonography |
Airway measurement will be done using ultrasonography and correlating it with difficulty in bag mask ventilation and direct laryngoscopy
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists physical status (ASA PS) I or II adult patients receiving general anaesthesia with orotracheal intubation with direct laryngoscopy for elective surgery.
|
|
| ExclusionCriteria |
| Details |
Patients with swelling/trauma/burns/abscess & hematoma in the neck region.
Patients with cervical spine injury.
Pregnant patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sensitivity, specificity, PPV, NPV and AUROC of USG measured airway parameters (HMDN, HMDE/HMDN, HMDR/HMDN, DSE, TT) in determining difficult direct laryngoscopy.
|
After performing the direct laryngoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Sensitivity, specificity, PPV, NPV & AUROC of USG measured airway parameters (DSE, TT) in predicting difficult mask ventilation.
2. Mean ± Standard Deviation (SD) cut off values of USG measured airway parameters (DSE, TT) in predicting difficult mask ventilation.
3. Mean ± SD cut off values of USG measured airway parameters (HMDN, HMDE/HMDN, HMDR/HMDN, DSE, TT) in predicting difficult direct laryngoscopy.
|
After performing the direct laryngoscopy |
|
|
Target Sample Size
|
Total Sample Size="268"
Sample Size from India="268"
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)
|
28/09/2025 |
| 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="2"
Days="15" |
|
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
|
USG measurements of airway
parameters have been found to correlate with Cormack-Lehane (CL) grading of
direct laryngoscopy with higher sensitivity and specificity. Distance between skin to epiglottis
(DSE), tongue thickness (TT), hyomental distance (HMD) and its ratio in
neutral, extended and ramped neck positions have been found to correlate with
grading of direct laryngoscopy. Very few studies in literature for
Indian population observing the relationship between USG measured parameters
and difficult direct laryngoscopy and difficult mask ventilation. Therefore,
present study was planned to evaluate these parameters for Indian population. |