| CTRI Number |
CTRI/2025/07/090667 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see different ultrasound parameters for predicting difficulty in laryngoscopy and endotracheal intubation and correlating it with the actual finding during Intubation |
|
Scientific Title of Study
|
Evaluation of different ultrasonographic parameters as predictors of
difficult laryngoscopy and endotracheal intubation |
| 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 Shraddha Shreyashi |
| Designation |
Junior resident |
| Affiliation |
T S Mista medical college and hospital |
| Address |
T S Misra medical college and hospital, Amausi, Lucknow, UP
Lucknow
UTTAR PRADESH
226009
India |
| Phone |
8709089869 |
| Fax |
|
| Email |
Shraddha.shreyashi40@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anurag Srivastava |
| Designation |
Associate Professor |
| Affiliation |
T S Mista medical college and hospital |
| Address |
T S Misra medical college and hospital, Amausi, Lucknow, UP
Lucknow
UTTAR PRADESH
226009
India |
| Phone |
8152831226 |
| Fax |
|
| Email |
dr.anurag.anaesthesiology@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shraddha Shreyashi |
| Designation |
Junior Resident |
| Affiliation |
T S Mista medical college and hospital |
| Address |
T S Misra medical college and hospital, Amausi, Lucknow, UP
Lucknow
UTTAR PRADESH
226009
India |
| Phone |
8709089869 |
| Fax |
|
| Email |
Shraddha.shreyashi40@gmail.com |
|
|
Source of Monetary or Material Support
|
| T S Misra medical college and hospital, Amausi, Lucknow, UP, 226009, India |
|
|
Primary Sponsor
|
| Name |
T S Mista medical college and hospital |
| Address |
T S Misra medical college and hospital, Amausi, Lucknow, UP 226009 |
| 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 Shraddha Shreyashi |
T S Misra medical college and hospital |
Preoperative room, 6th floor,T S Misra medical college and hospital
Lucknow
UTTAR PRADESH |
08709089869
Shraddha.shreyashi40@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, T S Misra medical college |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to give consent, ASA I, II, planned for GA with endotracheal intubation |
|
| ExclusionCriteria |
| Details |
Patients under ASA III/IV. Patient with facial fractures, cervical spine instability and patients requiring rapid
sequence intubation. Refusal to give consent
Patients with psychiatric illness and who are hemodynamically unstable. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To look into the sensitivity, specificity, positive predictive
and negative predictive values of different ultrasonographic parameters for
predicting difficult airway. To compare the above parameters between easy and
difficult laryngoscopy patients |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
19/07/2025 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This prospective observational study evaluated the role of ultrasonographic airway parameters in predicting difficult laryngoscopy and endotracheal intubation in 105 ASA I–II adult patients undergoing elective surgery. Preoperative ultrasound measurements included tongue thickness (TT), distance from skin to epiglottis (DSE), hyomental distance (HMD), hyomental distance ratio (HMDR), distance from skin to hyoid bone (DSHB), and distance from skin to vocal cords (DSVC). Airway difficulty was assessed using Cormack–Lehane grading and Intubation Difficulty Scale (IDS). Results showed that difficult laryngoscopy and difficult intubation occurred in 36.2% and 28.6% of patients respectively. Tongue thickness and DSE emerged as the most accurate predictors (AUC > 0.85), with higher values significantly associated with difficult airway. Ultrasonographic airway assessment is a reliable, non-invasive, and objective tool that improves prediction of difficult airway, with TT and DSE being the most useful parameters for routine clinical practice.
|