| CTRI Number |
CTRI/2025/08/093233 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
"Using Ultrasound to Predict Breathing Mask Difficulties Before Surgery"
|
|
Scientific Title of Study
|
Pre-operative Palatoglossal space evaluation by ultrasonography to predict difficult mask ventilation -a prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kishan Shimpi |
| Designation |
Junior resident |
| Affiliation |
SDM College of medical sciences and hospitals |
| Address |
S/o Ashok shimpi
At post shivalli Taluq Dharwad Dist Dharwad
Dharwad
KARNATAKA
580112
India |
| Phone |
7619144667 |
| Fax |
|
| Email |
kishanshimpi88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shilpa Agnihotri |
| Designation |
Additional professor |
| Affiliation |
SDM College of Medical Sciences and Hospital Dhawad |
| Address |
Department of anaesthesiology, SDM college of medical sciences and hospital, Dharwad.
Dharwad
KARNATAKA
580009
India |
| Phone |
9986066030 |
| Fax |
|
| Email |
docshilpa04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shilpa Agnihotri |
| Designation |
Additional professor |
| Affiliation |
SDM College of Medical Sciences and Hospital Dhawad |
| Address |
Department of anaesthesiology, SDM college of medical sciences and hospital, Dharwad.
Dharwad
KARNATAKA
580009
India |
| Phone |
9986066030 |
| Fax |
|
| Email |
docshilpa04@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of medical sciences and hospital sattur dharwad |
|
|
Primary Sponsor
|
| Name |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL SATTUR DHARWAD |
| Address |
SDM college of medical sciences and hospital, Sattur, Dharwad. |
| Type of Sponsor |
Private 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 |
| Kishan Shimpi |
SDM college of medical sciences and hospital |
Main OT complex and superspeciality OT complex, SDM college of medical sciences and hospital, Sattur, Dharwad.
Dharwad
KARNATAKA |
7619144667
kishanshimpi88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SDM college of medical science |
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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgeries under general anaesthesia requiring endotracheal tube.
ASA physical status 1,2,3.
|
|
| ExclusionCriteria |
| Details |
Modified anaesthesia protocol or cancellation of endotracheal intubation.
Patients with orofacial deformity or trauma.
Patients with established difficult airway. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We are expecting better prediction of difficult mask ventilation by measuring palatoglossal space allowing anesthesiologist to be prepared with necessary equipments and procedure |
Primary outcome will be assessed at baseline and 30seconds to 1 minutes after bag and mask ventilation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
29/08/2025 |
| 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 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
|
This prospective observational study includes 130 patients undergoing elective surgeries under general anaesthesia with endotracheal intubation at a tertiary care teaching hospital. It aims to assess airway parameters especially palatoglossal space PGS via ultrasound to predict difficult mask ventilation DMV and difficult intubation. Preoperative evaluation includes demographics BMI airway assessment with mouth opening Modified Mallampati grading and PGS measurement. After induction with fentanyl propofol and vecuronium mask ventilation is graded using Han scale and intubation is performed by a trained anaesthesiologist. Cormack Lehane CL grading is noted. DMV is defined as Han grade 3 or more and difficult intubation as CL grade 2B or more or requiring adjuncts like a bougie. The study correlates ultrasound based PGS measurements with airway management outcomes. |