| CTRI Number |
CTRI/2025/10/095666 [Registered on: 07/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Can ultrasound predict mask ventilation sucesss before anaesthesia |
|
Scientific Title of Study
|
Prediction of adequacy of mask ventilation by preoperative ultrasonographic evaluation of palatoglossal space in patients undergoing elective surgery under general anaesthesia |
| 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 Ranjith R T |
| Designation |
Post graduate resident |
| Affiliation |
ESIC Medical college Faridabad |
| Address |
118/3H
Godavari enterprises
NIT 3
Faridabad
Haryana
Faridabad
HARYANA
121012
India |
| Phone |
8667848358 |
| Fax |
|
| Email |
rtranjithbvsc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rama Wason |
| Designation |
Professor |
| Affiliation |
ESIC Medical college Faridabad |
| Address |
Department of Anaesthesiology
OT complex 3rd floor
ESIC Medical college
NIT 3
Faridabad
Faridabad
HARYANA
121012
India |
| Phone |
9818049948 |
| Fax |
|
| Email |
nupur4@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yawar Rashid |
| Designation |
Assistant Professor |
| Affiliation |
ESIC Medical college Faridabad |
| Address |
Department of Anaesthesiology
OT complex 3rd floor
ESIC Medical college Faridabad
NIT 3
Faridabad
Faridabad
HARYANA
121012
India |
| Phone |
9589891711 |
| Fax |
|
| Email |
yawarashid@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical college Faridabad
NIT 3
Haryana 121012 |
|
|
Primary Sponsor
|
| Name |
Dr Ranjith R T |
| Address |
ESIC Medical College
NIT 3 Faridabad
Haryana 121012 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| RANJITH R T |
ESIC Medical College |
ESIC Medical College
NIT 3 Faridabad
Haryan
Faridabad
HARYANA |
8667848358
rtranjithbvsc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex and age 18 to 55 years posted for elective surgery under general anaesthesia requiring endotracheal intubation |
|
| ExclusionCriteria |
| Details |
Cervical spine instability
Required rapid sequence intubation
Previous history of difficult intubation
Edentulous patients
Anatomical and pathological deformity of face and neck |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the width of Palatoglossal space ultrasonographically and correlate with difficulty in mask ventilation in patients undergoing elective surgery under general anaesthesia |
During preoperative period and intraoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Preoperative predictors of difficult mask ventilation
Measurement of tongue thickness in predicting difficult mask ventilation & difficult laryngoscopy |
During preoperative period & intraoperative period |
|
|
Target Sample Size
|
Total Sample Size="142"
Sample Size from India="142"
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)
|
14/10/2025 |
| 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 Yet Recruiting |
| 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
|
The study aims to evaluate whether preoperative ultrasound measurement of the palatoglossal space can help to predict the adequacy of mask ventilation in patients undergoing elective surgery under general anaesthesia. Difficult mask ventilation can lead to complications, so identifying patients at risk before anaesthesia is important. By assessing this space using ultrasound, we aim to provide a simple , non invasive tool to improve patient safety during anaesthesia |