| CTRI Number |
CTRI/2026/03/106971 [Registered on: 27/03/2026] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using Ultrasound to predict difficult windpipe tube placement for general Anaesthesia |
|
Scientific Title of Study
|
A Prospective Observational Study to predict Difficult Intubation using Ultrasound guided upper airway parameters |
| 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 JAYASHREE M |
| Designation |
FIRST YEAR DNB ANAESTHESIA CANDIDATE |
| Affiliation |
SRI NARAYANI HOSPITAL AND RESEARCH CENTRE |
| Address |
SRI NARAYANI HOSPITAL AND RESEARCH CENTRE
DEPARTMENT OF ANAESTHESIOLOGY
SRIPURAM
VELLORE
Vellore TAMIL NADU 632055 India |
| Phone |
8489827607 |
| Fax |
|
| Email |
jayashreevasuki1312@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr SIDDARTHA SEEKALA |
| Designation |
CONSULTANT ANAESTHETIST |
| Affiliation |
Sri Narayani Hospital and Research Institute |
| Address |
SRI NARAYANI HOSPITAL AND RESEARCH CENTRE
DEPARTMENT OF ANAESTHESIOLOGY
SRIPURAM
VELLORE
Vellore TAMIL NADU 632055 India |
| Phone |
9482042919 |
| Fax |
|
| Email |
Seekala@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr SIDDARTHA SEEKALA |
| Designation |
CONSULTANT ANAESTHETIST |
| Affiliation |
Sri Narayani Hospital and Research Institute |
| Address |
SRI NARAYANI HOSPITAL AND RESEARCH CENTRE
DEPARTMENT OF ANAESTHESIOLOGY
SRIPURAM
VELLORE
Vellore TAMIL NADU 632055 India |
| Phone |
9482042919 |
| Fax |
|
| Email |
Seekala@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI NARAYANI HOSPITAL AND RESEARCH CENTRE SRIPURAM 632055 VELLORE TAMIL NADU INDIA |
|
|
Primary Sponsor
|
| Name |
SRI NARAYANI HOSPITAL AND RESEARCH CENTRE |
| Address |
SRIPURAM 632055
VELLORE
TAMIL NADU 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 Jayashree M |
SRI NARAYANI HOSPITAL AND RESEARCH CENTRE |
OPERATION THEATRE OF C BLOCK 1ST FLOOR AND A BLOCK 2ND FLOOR
DEPARTMENT OF ANAESTHESIOLOGY Vellore TAMIL NADU |
8489827607
jayashreevasuki1312@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Narayani Hospital Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B||Imaging, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex
Age between18 to 70yrs
ASA physical status I to III
|
|
| ExclusionCriteria |
| Details |
Patients with upper airway anomalies
Patients with Head and Neck Trauma
Tumours of nose, oral cavity and neck
History of Difficult Intubation
Cervical spine pathologies
Patient refusal for the procedure
Patients requiring nasal intubation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A favorable outcome is expected towards the Ultrasonography guided measurement of upper airway parameters in predicting difficult intubation |
0 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
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)
|
06/04/2026 |
| 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="0" 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
|
Airway management remains a crucial part of perioperative care. The Conventional approach to assessing potential difficult airway emphasises use of clinical parameters such as Mallampati classification, Neck mobility, Thyromental distance, Inter-incisor gap, Mouth opening etc. Clinical findings help predict a higher likelihood of difficult tracheal intubation, but no clinical result is reliable to exclude difficult intubation. ULTRASOUND as an adjunct to Clinical Examination can provide the Clinician with a dynamic anatomical airway assessment. Several USG measurements such as TONGUE THICKNESS, SOFT TISSUE THICKNESS AT THE LEVEL OF HYOID BONE, SOFT TISSUE THICKNESS AT THE LEVEL OF THYROHYOID MEMBRANE, SOFT TISSUE THICKNESS AT THE LEVEL OF VOCAL CORD are preferred in this study considering ease and rapidity in locating anatomical landmarks which allows precise measurements and their potential ability to predict DIFFICULT INTUBATION. In this study myself under the guidance of Dr Siddartha Seekala will be assessing the upper airway of the patients during preoperative assessment clinic followed by Ultrasound guided upper airway examination with informed consent prior to the time of induction of general anaesthesia. The measurements will be noted and formulated into study analysis. A favourable outcome is expected leaning more towards the aforesaid ultrasound guided upper airway parameters to predict the difficult intubation in relation to the conventional upper airway assessment. |