| CTRI Number |
CTRI/2025/08/093261 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Comparing the effectiveness of compression using the accessory devices ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The impact of using a step tool and a CPR board by nursing students while giving chest compression during cardiac arrest on a simulated manikin for quality compression of the chest |
|
Scientific Title of Study
|
The impact of a step stool and a CPR board during cardiopulmonary resuscitation (CPR)A randomized controlled trial manikin-based simulation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poonam Joshi |
| Designation |
Professor cum Principal |
| Affiliation |
AIIMS Kalyani |
| Address |
Room No. 401, 4th Floor, College of Nursing, AIIMS KALYANI, Basa natapur, Nadia District
Nadia
WEST BENGAL
741245
India |
| Phone |
9818039744 |
| Fax |
|
| Email |
poonam.nursing@aiimskalyani.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Poonam Joshi |
| Designation |
Professor cum Principal |
| Affiliation |
AIIMS Kalyani |
| Address |
Room No. 401, 4th Floor, College of Nursing, AIIMS KALYANI, Basa natapur, Nadia District
Nadia
WEST BENGAL
741245
India |
| Phone |
9818039744 |
| Fax |
|
| Email |
poonam.nursing@aiimskalyani.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Poonam Joshi |
| Designation |
Professor cum Principal |
| Affiliation |
AIIMS Kalyani |
| Address |
Room No. 401, 4th Floor, College of Nursing, AIIMS KALYANI, Basa natapur, Nadia District
Nadia
WEST BENGAL
741245
India |
| Phone |
9818039744 |
| Fax |
|
| Email |
poonam.nursing@aiimskalyani.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Poonam Joshi |
| Address |
Room No. 401, 4th Floor, College Of Nursing, AIIMS Kalyani, Basnatapur, Nadia District, West Bengal 741245 |
| 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 Poonam Joshi |
AIIMS Kalyani |
Room No. 301, Simulation Lab, College of Nursing, AIIMS Kalyani, Basnatapur, Nadia District, West Bengal 741245
Nadia
WEST BENGAL |
9818039744
poonam.nursing@aiimskalyani.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| AIIMS Kalyani |
Submittted/Under Review |
| IEC, AIIMS kalyani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Accessory use such as foot stool, CPR board alone or combined |
Accessory use such as foot stool, CPR board alone or combined will be provided to the students for performing cardiopulmonary resuscitation on manikins |
| Comparator Agent |
Standard method |
students will be asked to perform cardiopulmonary resuscitation normally as part of standard care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
BSc (Hons) Nursing students
Age 18 to 30 years
Ability to perform CPR for at least 2 minutes without stopping
|
|
| ExclusionCriteria |
| Details |
BSc (Hons) Nursing students having any kind of physical limitations, such as pain, fracture or injury, etc., preventing them from providing chest compression |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Compression depth and rate
Recoil and hand placement accuracy
Fatigue levels in rescuers
Time to initiate compressions
|
one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Fatigue levels in rescuers
Time to initiate compressions
|
one time |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/10/2025 |
| 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="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
|
A prospective randomized controlled trial will be conducted in which nursing students’ ability to provide effective CPR on a manikin in a simulation lab will be assessed in terms of Full Recoil (percentage), Correct Hand Placement (percentage), Rescuer Fatigue (self-reported using a validated scale) and Time to Initiation of Effective Compressions (seconds) will be assessed using a QCPR app ( available in play store) |