| CTRI Number |
CTRI/2025/08/093097 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ultrasonography guided measurement of airway structures to predict difficulty during laryngoscopy.
|
|
Scientific Title of Study
|
Ultrasound guided Measurement Of Mandible -Hyoid Bone - Glottis Angle & Distance From Glottis To The Upper Edge Of The Thyroid Cartilage to Predict 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 Priti Devalkar |
| Designation |
Associate Professor |
| Affiliation |
Seth G S Medical College and KEM Hospital |
| Address |
Department of Anaesthesiology , 1st floor old building ,Kem hospital,acharya donde marg,parel,mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
97699344980 |
| Fax |
|
| Email |
devalkarprit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priti Devalkar |
| Designation |
Associate Professor |
| Affiliation |
Seth G S Medical College and KEM Hospital |
| Address |
Department of Anaesthesiology , 1st floor old building ,Kem hospital,acharya donde marg,parel,mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
97699344980 |
| Fax |
|
| Email |
devalkarprit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAaditya Gangawane |
| Designation |
Junior Resident |
| Affiliation |
Seth G S Medical College and KEM Hospital |
| Address |
Department of Anaesthesiology , 1st floor old building ,Kem hospital,acharya donde marg,parel,mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9168734877 |
| Fax |
|
| Email |
aaditya.gangawane44@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1st floor,Department of Anaesthesiology,Seth GS Medical College and KEM Hospital,Parel,Mumbai-400012. |
|
|
Primary Sponsor
|
| Name |
Seth GS Medical College and KEM Hospital |
| Address |
Acharya Donde Marg,Parel,Mumbai-400012.Maharashtra,India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Priti Devalkar |
Seth G S Medical College and KEM Hospital |
Department of Anaesthesiology , 1st floor old building ,Kem hospital,acharya donde marg,parel,mumbai
Mumbai
MAHARASHTRA |
97699344980
devalkarpriti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC(lll)RELATING TO BIOMEDICAL AND HEALTH RESEARCH SETH GS MEDICAL COLLEGE AND KEM HOSPITAL MUMBAI |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients posted for elective surgeries under GA with tracheal intubation
2. ASA 1&2 |
|
| ExclusionCriteria |
| Details |
1. Pregnancy
2. Obese patients.
3. Patients with maxillofacial deformities or fractures.
4. Cervical spine instability.
5. Patients requiring rapid sequence induction.
6. Patients who refused to give consent.
7. Patients with neck swelling. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To perform usg guided measurements of angle between mandible-hyoid bone-glottis and distance from glottis to the upper edge of thyroid cartilage. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate the above mentioned usg parameters with cormack lehane grading to predict difficult laryngoscopy. |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="97"
Sample Size from India="97"
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)
|
15/09/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Airway assessment is an essential aspect of pre-anaesthesia evaluation. Until now many traditional bedside clinical predictors were used to predict difficult laryngoscopy. However these parameters have limited specificity to diagnose unanticipated difficult airway.Studies have shown that non-invasive ultrasonography is used for evaluating upper airway anatomy and calculate distances between anatomical structures which can aid in prediction of difficult laryngoscopy. Aim of our study is to predict difficult laryngoscopy by USG guided measurement of the angle between mandible - hyoid Bone - glottis and distance from the glottis to the upper edge of thyroid cartilage. Primary objective of this study is to perform USG guided measurement of angle between mandible - hyoid Bone - glottis and distance from the glottis to the upper edge of thyroid cartilage and secondary objective. is to correlate the above-mentioned USG parameters with cormack lehane grading to predict difficult laryngoscopy. Our study is prospective interventional study performed in operation theatres. The sample size of this study is 97 based on statistical analysis. The subjects will be selected based on inclusion criteria like age >18yrs & <65 yrs, patients posted for elective surgeries under GA with tracheal intubation, ASA I&II. Pregnancy patients, obese patients, patients with maxillofacial deformities or fractures, cervical spine instability, patients requiring rapid sequence induction, patients who refused to give consent ,patients with neck swelling will be excluded. The methodology of this study is that on previous day of surgery pre-op anaesthesia evaluation will be done for measurement of usg parameters patient will be placed in supine position with their head and neck in maximal extension and usg of airway will be done by anaesthetist and angle between mandible-hyoid bone and glottis and distance from the glottis to the upper edge of the thyroid cartilage will be measured.On the day of surgery patient will be positioned in sniffing position using a head ring and after the induction of general anaesthesia direct laryngoscopy with macintosh blade will be performed by other anaesthetist who will be blinded to usg measurements and cormack lehane grade of larynx will be noted. The differences will be assessed with the help of statistician. |