| CTRI Number |
CTRI/2025/08/092225 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Check How Well the DiffMask Score Can Predict Difficulty in Giving Breathing Support Using a Mask During Anesthesia
|
|
Scientific Title of Study
|
Accuracy of DiffMask Score in predicting 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 |
Thameena Syed Gaffar |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
6382767587 |
| Fax |
|
| Email |
thameena.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savan Kumar Nagesh |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Department of Anaesthesiology, Kasturba Hospital, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8105308865 |
| Fax |
|
| Email |
savan.nagesh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Thameena Syed Gaffar |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
6382767587 |
| Fax |
|
| Email |
thameena.mchpmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital and Medical College , Manipal, Udupi, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Thameena Syed Gaffar |
| Address |
Anaesthesia and Operation Theartre Technology Program ,5th floor ,Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka , India ,576104 |
| 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 |
| Dr Savan Kumar Nagesh |
Kasturba Medical College and Kasturba Hospital |
Operation Theatre Complex, 1st Floor, Main OT Block, Manipal, 576104
Udupi
KARNATAKA |
8105308865
savan.nagesh@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kasturba medical college and kasturba hospital Institutional Ethics committee -2 (student Research) |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Participants undergoing elective surgery under General Anaesthesia |
|
| ExclusionCriteria |
| Details |
Participants planned for Awake Intubation
Participants with full stomach and facial fracture surgery
Pregnant women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of difficult mask ventilation score as per Han scale greater than 2 |
Preoperatively and Intraoperatively on the day of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="328"
Sample Size from India="328"
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)
|
01/08/2025 |
| 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="0"
Months="8"
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
|
The DiffMask Score is a retrospective registry-based study which was validated using retrospective
cohort control group data. As the score needs external validation and testing for accuracy, this study
focuses on finding the accuracy of the DiffMask score in predicting DMV by a prospective observational
study. |