| CTRI Number |
CTRI/2025/04/083916 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
31/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Randomized Control Observer Blinded Trial |
| Study Design |
Other |
|
Public Title of Study
|
Effect of technical knowledge about simulation crisis
scenario on Anaesthesiologists Non technical Skills . |
|
Scientific Title of Study
|
Effect of pre-session technical knowledge about simulation crisis
scenario on performance of non-technical skills by participants- A
randomized controlled observer blinded trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saundarya Monga |
| Designation |
Junior Resident , Department of Anaesthesiology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesia, Pain Medicine and Critical Care , AIIMS , New Delhi.
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
South
DELHI
110029
India |
| Phone |
8178077076 |
| Fax |
|
| Email |
saundaryamonga@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rashmi Ramachandran |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesia, Pain Medicine and Critical Care , AIIMS , New Delhi.
South
DELHI
110029
India |
| Phone |
919811422188 |
| Fax |
|
| Email |
rashmiramachandran1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saundarya Monga |
| Designation |
Junior Resident, Department of Anaesthesiology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesia, Pain Medicine and Critical Care , AIIMS , New Delhi.
South
DELHI
110029
India |
| Phone |
8178077076 |
| Fax |
|
| Email |
saundaryamonga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia , Pain Medicine and Critical Care ,All India Institute of Medical Sciences, New Delhi. |
|
|
Primary Sponsor
|
| Name |
Rashmi Ramachandran |
| Address |
Department of Anaesthesia , Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi |
| Type of Sponsor |
Other [Other (Self ) ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Anaesthesia Pain Medicine and Critical Care |
All India Institute of Medical Sciences,Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Saundarya Monga |
All India Institute of Medical Sciences, New Delhi |
AB9 Classroom and simulation lab, 8th floor , Department of Anaesthesiology, Pain medicine and critical care, AIIMS New Delhi.
South
DELHI |
8178077076
saundaryamonga@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Technical Aid during crisis scenario in the form of a flowchart on guidelines regarding various crisis scenarios in OT setting : Sudden bradycardia management , anaphylaxis management, etc . |
We will be providing one group with a technical Aid ( in form of a flowchart) containing details pertaining to the crisis scenario in the simulation. The other group will not get any technical aid. Both groups will undergo the same crisis scenario where their Non techical skills will be assessed using ANTS scores by experienced faculty members. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Junior Residents in the Department of Anaesthesiology, AIIMS New Delhi. |
|
| ExclusionCriteria |
| Details |
Does not give consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of pre-simulation knowledge about technical management of crisis scenarios on the development of non-technical skills (NTS) in learners with the help of ANTS Score. (Anesthesiologists Non-Technical Skills Score) |
ANTS Score. (Anesthesiologists Non-Technical Skills Score) at 30mins time approximately , that is ,after the simulation scenario is complete. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Participant satisfaction score regarding simulation sessions |
30 mins to 1 hour after simulation scenario is over. |
| Global rating score of the participants |
30 mins to 1 hour after simulation scenario is over. |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
20/04/2025 |
| 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="0"
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
|
Participants will be block randomized to either pre simulation group (PSK) or control (C) group. Intervention : Pre simulation knowledge session on medical and technical management of patient centered crisis. Control group : No pre simulation knowledge will be provided to the participants. Rest of the session will be conducted as described for intervention group.
|