| CTRI Number |
CTRI/2025/08/093319 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of a Low-Cost Manikin for Resuscitation (CPR) Training of Middle School Students |
|
Scientific Title of Study
|
Comparison Between Quality Of Chest Compressions and Knowledge About Compression Only Life Support With a Low-Cost Manikin Versus a Commercial Manikin: A Quasi-Experimental Study In Middle School Students |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sadhana Kulkarni |
| Designation |
Professor Emeritus Department Of Emergency Medicine |
| Affiliation |
MGM Medical College and Hospital Aurangabad MAHARASHTRA 431003 India |
| Address |
Department Of Emergency Medicine, MGM Medical College and Hospital Aurangabad MAHARASHTRA 431003 India
Aurangabad MAHARASHTRA 431003 India |
| Phone |
9763350977 |
| Fax |
|
| Email |
kulkarnisadhana@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sadhana Kulkarni |
| Designation |
Professor Emeritus Department Of Emergency Medicine |
| Affiliation |
MGM Medical College and Hospital Aurangabad MAHARASHTRA 431003 India |
| Address |
Department Of Emergency Medicine, MGM Medical College and Hospital Aurangabad MAHARASHTRA 431003 India
Aurangabad MAHARASHTRA 431003 India |
| Phone |
9763350977 |
| Fax |
|
| Email |
kulkarnisadhana@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sadhana Kulkarni |
| Designation |
Professor Emeritus Department Of Emergency Medicine |
| Affiliation |
MGM Medical College and Hospital Aurangabad MAHARASHTRA 431003 India |
| Address |
Department Of Emergency Medicine, MGM Medical College and Hospital Aurangabad MAHARASHTRA 431003 India
Aurangabad MAHARASHTRA 431003 India |
| Phone |
9763350977 |
| Fax |
|
| Email |
kulkarnisadhana@yahoo.com |
|
|
Source of Monetary or Material Support
|
| MGM Medical College and Hospital Aurangabad Maharashtra |
|
|
Primary Sponsor
|
| Name |
MGM Medical College and Hospital Aurangabad |
| Address |
MGM Medical College and Hospital Aurangabad MGM Campus N6 Cidco MAHARASHTRA 431003 India. |
| 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 Sadhana Sudir Kulkarni |
MGM Medical College and Hospital, Aurangabad |
Medical education and Skill Development Unit, Opp MCRI Casualty Aurangabad MAHARASHTRA |
9763350977
kulkarnisadhana@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy students with no active disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Commercial manikin group |
Commercial manikin group, comparator group, students will be trained for COLS skill training by using the commercial manikin, Little Anne Q-CPR Laerdal manikin. The metronome app on mobile will be used as audio feedback during practice.
4 instructors will train 25 students, on Commercial manikin during a 30-minute session.
After practice , commercial manikin group student will be assessed on Little Anne Q-CPR Laerdal manikin for rate, depth and chest recoil during chest compressions as per the study published in the American Journal of Emergency Medicine in 2023 .
Coordinators will assess cognitive skills through validated MCQs as a post-test after skill assessment. Feedback will be collected regarding the training program.
|
| Intervention |
Low Cost Mannequin |
COLS Knowledge will be assessed by a pretest in all the students.
Low cost manikin group, intervention group, students will be trained for COLS skill training by using Low cost manikin. The metronome app on mobile will be used as audio feedback during practice.
4 instructors will train 25 students, on low cost manikin during a 30-minute session.
After practice, low cost manikin group student will be assessed on Little Anne Q-CPR Laerdal manikin for rate, depth and chest recoil during chest compressions as per the study published in the American Journal of Emergency Medicine in 2023.
Coordinators will assess cognitive skills through validated MCQs as a post-test after skill assessment. Feedback will be collected regarding the training program and low cost manikin utility.
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.110 Students of 6th and 110 students of 7th standard willing to provide written informed assent and parents’ consent form to participate in the study
2. Any physical or mental impairment, systemic disorder detected after medical check-up
3. Previous experience/ information (theoretical or practical) in cardiopulmonary resuscitation.
4. Students well versed in English as well as in Marathi, the languages used as medium of instructions for training and MCQ test for assessment of knowledge.
|
|
| ExclusionCriteria |
| Details |
1. Any physical or mental impairment, systemic disease
2. Previous experience/ information (theoretical or practical) in cardiopulmonary resuscitation.
3. Students not well versed in English as well as in Marathi language.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the psychomotor skills of school children
trained by using low cost and commercial manikin.
And to compare the psychomotor skills of school children
trained by using low cost and commercial manikin.
|
5 minutes after completion of practice session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess cognitive skills of school childrentrained by using low cost and commercial manikin
2.To compare cognitive skills of school children trained by using low cost and commercialmanikin
3.To collect feedback from the participants &investigatorsregarding utility of low-cost manikins for COLS training.
|
Cognitive assessment will be done by coordinators at Baseline(0 hours) and 15 minutes after skill assessment.
Student feedback about training program will be taken 25 minutes after skill assessment by the coordinators. LCM group students’ feedback about utility of low-cost manikin will be taken 35 minutes after skill assessment by the coordinators.Faculty feedback about low-cost manikin will becollected at the end of training. 4 hours (after completion of lecture cum demonstration, video and hands on training of COLS and skill assessment test of all students)after starting the training.
|
|
|
Target Sample Size
|
Total Sample Size="210" Sample Size from India="210"
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)
|
12/09/2025 |
| 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="7" 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 - YES
- What data in particular will be shared?
Response (Others) - Data related with tables
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kulkarnisadhana@yahoo.com].
- For how long will this data be available start date provided 15-04-2026 and end date provided 15-04-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Cardiopulmonary resuscitation CPR is a lifesaving skill that significantly improves survival rates following outofhospital cardiac arrest OHCAnothing with bystander intervention doubling or tripling the likelihood of survival Schoolbased CPR training programs are effective platforms for equipping young individuals with these skills and increasing the number of CPR bystanders which is less than 5 percent in our societyThe high cost and limited availability of commercial manikins often limit access to CPR training in resourceconstrained settings This affects low and middleincome regions where innovative costeffective solutions are urgently needed to help CPR educationLowcost manikins made from locally available materials like Polyethylene terephthalate PET bottles and inhouse developed natural rubber manikin bottles are explored to address this challenge These alternatives demonstrated effective feedback and user satisfaction according to trial published in African Journal of Emergency Medicine 2021 Building on this the use of waste plastic abundant and often discarded in communities worldwide presents a novel opportunity to create indigenous manikins by reusing it This will also address environmental concerns about plastic pollution Very few studies have compared the efficacy of indigenous manikins made from waste materials to commercial manikins in school children who are prime candidates for communitywide CPR dissemination The training tools can affect skill acquisition and trainee confidence with implications for realworld performanceThe present study aims to evaluate the utility of an indigenous manikin crafted from waste plastic compared to a commercial manikin for training school students in compressiononly life support We also used the audio feedback device easily accessible on the mobile App metronome during training By assessing skill performance knowledgeand trainee satisfaction we seek to determine whether a lowcost manikin can match the effectiveness of commercial equipment The present study will respond to the global call for CPR education in every part of the world
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