| CTRI Number |
CTRI/2025/08/093214 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
16/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Ultrasound study of the space between the tongue and the soft palate with and without jaw protrusion to predict difficulty in mask ventilation during anaesthesia |
|
Scientific Title of Study
|
Ultrasonographic evaluation of palatoglossal space with and without jaw protrusion as a predictor of difficult mask ventilation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aswath Narayana S J |
| Designation |
Post Graduate Resident |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8526064320 |
| Fax |
|
| Email |
achuattips@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amita Gupta |
| Designation |
Professor and consultant |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9910382190 |
| Fax |
|
| Email |
amitaguptadr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amita Gupta |
| Designation |
Professor and consultant |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9910382190 |
| Fax |
|
| Email |
amitaguptadr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia and intensive care, Vardhaman Mahavir medical College and
Safdarjung hospital, Ansari Nagar East, New Delhi,India |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of anaesthesia and intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar East, New Delhi |
| 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 Aswath Narayana S J |
Vardhman Mahavir medical college and Safdarjung hospital |
Department of anaesthesia and
intensive care, Ansari
nagar East, New Delhi 110029
New Delhi
DELHI |
8526064320
achuattips@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital 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 |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18-65 years undergoing elective surgery
under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway requiring planned awake intubation
Patients requiring rapid sequence induction of anaesthesia
Patients having congenital syndromes with facial abnormalities
Patients with history of burns, trauma and tumor in and around oral cavity and neck |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ultrasonographic assessment of palatoglossal space with and without jaw protrusion in predicting difficult mask ventilation |
Ultrasonographic evaluation of palatoglossal space in the preoperative holding area, within 30 minutes before shifting the patient to the operation theatre.
Difficult mask ventilation is assessed after induction, during attempt at mask ventilation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ultrasonographic assessment of palatoglossal space with & without jaw protrusion in predicting difficult laryngoscopy & ultrasonographic assessment of tongue thickness in predicting difficult mask ventilation & difficult laryngoscopy |
Ultrasonographic evaluation of palatoglossal space & tongue thickness in the preoperative holding area, within 30 minutes before shifting the patient to the operation theatre
Difficult mask ventilation is assessed after induction, during attempt at mask ventilation
Difficult laryngocopy is assessed immediately after mask ventilation, during attempt at laryngocopy
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
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
|
Safe and effective airway management is a cornerstone of anesthetic practice. Difficult mask ventilation (DMV) can lead to serious complications if not anticipated early. As such, accurate predictors of DMV are essential for preoperative airway assessment. In recent years, ultrasonography has emerged as a non-invasive, bedside tool for dynamic airway evaluation. Several studies have explored the use of ultrasound-based assessments as a reliable approach for predicting difficult airways. But, There is paucity of literature on ultrasound based assessment of palatoglossal space with and without jaw protrusion as a predictor of difficult mask ventilation in adult patients. The purpose of this study is to evaluate the role of ultrasound assessment of palatoglossal space with and without jaw protrusion in predicting difficult mask ventilation. |