| CTRI Number |
CTRI/2026/01/100714 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| 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 soft palate to predict difficulty in mask ventilation during anaesthesia in adults of different age groups |
|
Scientific Title of Study
|
Ultrasonographic assessment of Palatoglossal space as a Predictor of Difficult Bag mask ventilation in adults of different age groups |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramila A Suthar |
| 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 |
9571735769 |
| Fax |
|
| Email |
ramilasuthar1234@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 |
| Ramila A Suthar |
Vardhman Mahavir Medical College and Safdarjung hospital |
Department of Anaesthesia and Intensive care, Ansari nagar East, New Delhi 110029
New Delhi
DELHI |
9571735769
ramilasuthar1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vmmc and Sjh institutional 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 18 to 65 years planned for elective surgery under general anesthesia |
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway requiring planned awake intubation
Patients requiring rapid sequence induction of anesthesia
Patients having congenital syndromes with facial abnormalities
Patients with history of burns,trauma and tumor in and around the oral cavity,neckor cervical spine |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine sensitivity and specificity of ultrasonographic measurement of palatoglossal space as a predictor of difficult bag mask ventilation in adults of different age groups(above 18 years)using Han score |
To determine sensitivity and specificity of ultrasonographic measurement of palatoglossal space in the preoperative holding area within thirty minutes before shifting the patient to the operation theatre. Difficult bag mask ventilation is assessed after induction during attempt at mask ventilation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine sensitivity & specificity of ultrasonographic measurement of palatoglossal space as a predictor of difficult laryngoscopy in adults of different age groups using Cormack Lehane Grading. |
Ultrasonographic evaluation of palatoglossal space in preoperative holding area,within 30 minutes before shifting the patient to the operation theatre.
Difficult bag mask ventilation is assessed after induction, during attempt at mask ventilation.
Difficult laryngoscopy is assessed immediately after mask ventilation during attempt at laryngoscopy |
| To determine sensitivity & specificity of ultrasonographic measurement of tongue thickness as a predictor of difficult bag mask ventilation using Han score & difficult laryngoscopy using cormack lehane grading in adults of different age groups |
Ultrasonographic evauation of tongue thickness in preoperative holding area,within thirty minutes before shifting the patient to the operation theatre. Difficult bag mask ventilation is assessed after induction during attempt at mask ventilation.
Difficult laryngoscopy is assessed immediately after mask ventilation during attempt at laryngoscopy. |
|
|
Target Sample Size
|
Total Sample Size="113"
Sample Size from India="113"
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)
|
22/01/2026 |
| 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="6"
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
|
Difficult airway management is of paramount importance in anesthesia. Mask ventilation is a noninvasive technique for airway management that can be used as a primary mode of ventilation. Several bedside physical airway assessment tests are available but they have a high interobserver variability and moderate to fair sensitivity and specificity. Ultrasonographic assessment of palatoglossal space is a novel approach for airway assessment and has been proposed as a potential predictor of difficult bag and mask ventilation. Since bag mask ventilation has been found to be difficult in elderly age groups in various studies, we decided to conduct a study to assess whether ultrasonographic assessment of palatoglossal space can predict difficult bag mask ventilation in adults of different age groups. |