| CTRI Number |
CTRI/2025/09/095223 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
21/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Medical education |
| Study Design |
Other |
|
Public Title of Study
|
Development of curriculum for paediatric anaesthesia |
|
Scientific Title of Study
|
Translating competencies to practice through Entrustable Professional Activity (EPA) based pediatric anesthesia training module- A developmental 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 |
Balasubramaniam Gayathri |
| Designation |
Professor Head |
| Affiliation |
SRM MCH RC SRMIST Chennai |
| Address |
ROOM NO B 2 07
SRM Medical College Hospital and Research Centre Kattankulathur
Chengalpattu
Tamil Nadu
Chennai
TAMIL NADU
600100
India |
| Phone |
09500092905 |
| Fax |
|
| Email |
gayathrb@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Balasubramaniam Gayathri |
| Designation |
Professor Head |
| Affiliation |
SRM MCH RC SRMIST Chennai |
| Address |
ROOM NO B 2 07
SRM Medical College Hospital and Research Centre Kattankulathur
Chengalpattu
Tamil Nadu
ROOM NO B 2 07
SRM Medical College Hospital and Research Centre Kattankulathur
Chengalpattu
Tamil Nadu
Chennai
TAMIL NADU
600100
India |
| Phone |
09500092905 |
| Fax |
|
| Email |
gayathrb@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Balasubramaniam Gayathri |
| Designation |
Professor Head |
| Affiliation |
SRM MCH RC SRMIST Chennai |
| Address |
ROOM NO B 2 07
SRM Medical College Hospital and Research Centre Kattankulathur
Chengalpattu
Tamil Nadu
Chennai
TAMIL NADU
600100
India |
| Phone |
09500092905 |
| Fax |
|
| Email |
gayathrb@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre Kattankulathur
Chengalpattu
Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital and Research Centre |
| Address |
Room No B 2 07
SRM Medical College Hospital and Research Centre Kattankulathur Chengalpattu Tamil Nadu 603203 |
| 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 |
| Dr B GAYATHRI |
SRM Medical College Hospital and Research Centre |
Room no B 2 07 SRM Medical College Hospital and Research Centre Kattankulathur Chengalpattu Tamil Nadu 603203
Kancheepuram
TAMIL NADU |
09500092905
gayathrii.r@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Curriculum development for MD anaesthesia graduates |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Anesthesia educators who are also involved in medical education having working knowledge about competencies and entrustable professional activities |
|
| ExclusionCriteria |
| Details |
Anaesthesia educators who are not willing to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of entrustable professional activities which are observable tasks (EPAs) which are performed by graduate anesthetists unsupervised |
Development of module 6 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
30/10/2025 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a developmental study, which involves study of competencies in MD Anaesthesia curriculum defined by NMC. The study aims to elucidate the competencies for safe paediatric anesthesia practice by developing units of unsupervised activities which can be entrusted to MD Anesthesia graduates. The developed EPAs will be validated by anaesthesia experts with strong medical education background through Delphi process |