| CTRI Number |
CTRI/2025/08/093720 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational Intervention] |
| Study Design |
Other |
|
Public Title of Study
|
Improving Trauma resuscitation and infection control in ambulances through medical simulation |
|
Scientific Title of Study
|
Development and Evaluation of Pre Hospital Resuscitation Kits for Trauma and Infectious Disease in Advanced Life Support ALS Ambulances A Simulation-Based Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avinash Bhat |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Professions MAHE Manipal |
| Address |
Department of Emergency Medical technology Manipal College of Health Professions MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7022990954 |
| Fax |
|
| Email |
avinash.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Freston Marc Sirur |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College and Hospital MAHE Manipal |
| Address |
Department of Emergency Medicine Kasturba Medical College and Hospital MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9604200804 |
| Fax |
|
| Email |
freston.sirur@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Freston Marc Sirur |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College and Hospital MAHE Manipal |
| Address |
Department of Emergency Medicine Kasturba Medical College and Hospital MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9604200804 |
| Fax |
|
| Email |
freston.sirur@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Emergency Medicine Kasturba Medical College Manipal Academy of Higher Education Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal Academy of Higher Education |
| Address |
Kasturba Medical College and Hospital Madhava Nagar Manipal Udupi Karnataka 576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Avinash Bhat |
Kasturba Hospital Manipal |
Department of Emergency Medicine Kasturba Medical College Manipal Academy of Higher Education
Udupi
KARNATAKA |
7022990954
avinash.mchpmpl2024@learner.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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nil
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Educational Interventional |
Development and evaluation of a new Pre-Hospital Resuscitation and Infection Control Kit through high-fidelity simulation. Participants will perform timed scenarios using both standard and new kits. Contamination levels and user feedback on ergonomics and usability will be assessed. |
| Comparator Agent |
Educational Interventional |
Existing Advanced Life Support (ALS) ambulance kits currently used in pre-hospital emergency care settings. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
EMTs and Paramedics are currently working in the pre-hospital setting, including the EMTs who are under training.
Participants securing at least 50% in the Pre-Test Questionnaire
|
|
| ExclusionCriteria |
| Details |
Nurses
Participants with pre-existing medical conditions, allergies to the glow powder, equipment used during the simulation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Positive qualitative assessment of the new Pre Hospital Resuscitation kits. |
At Baseline (Immediately after the assessment of the Traditional Advanced Life support Ambulance kits) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced transmissibility and reduced time to standardized care in the simulation model. |
The kits integrated infection control components and organized layout support safer and faster intervention delivery during pre-hospital emergencies. |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/08/2025 |
| 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="0"
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 study involves the development and evaluation of a new Pre Hospital Resuscitation Kit and an Infection Control Kit, guided by standard operating procedures and expert validation. After obtaining ethical approvals and informed consent, participants will be enlisted and oriented for a high-fidelity simulation conducted in an ALS ambulance setup. The simulation includes 28 scenarios 14 using traditional kits and 14 with the newly developed kits with performance time recorded. Contamination levels will be assessed using UV powder and image analysis to evaluate surface contact. Participant feedback will be collected through a validated questionnaire focusing on ergonomics, completeness, and usability of the kits. Data will be analyzed using JAMOVI 4.0, with statistical methods including test-retest and stratified analysis. |