| CTRI Number |
CTRI/2025/04/083892 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [quality of compression on a manikin during Cardiopulmonary Resuscitation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing the quality of chest compression using a feedback device |
|
Scientific Title of Study
|
Comparing the effectiveness of cardiopulmonary
resuscitation training using QCPR and conventional CPR methods among the
final year nursing students: A randomized controlled 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 |
Poonam Joshi |
| Designation |
Professor cum Principal |
| Affiliation |
AIIMS Kalyani |
| Address |
Room No. 401, 4th Floor, College of Nursing, AIIMS Kalyani
Type 5, House No. 404, AIIMS Kalyani, Basantapur, Nadia District West Bengal
Nadia
WEST BENGAL
741245
India |
| Phone |
09818039744 |
| Fax |
|
| Email |
poonam.nursing@aiimskalyani.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Poonam Joshi |
| Designation |
Professor cum Principal |
| Affiliation |
AIIMS kalyani |
| Address |
College of Nursing, AIIMS Kalyani
Type 5, House No. 404, AIIMS Kalyani, Basantapur, Nadia District West Bengal
Nadia
WEST BENGAL
741245
India |
| Phone |
09818039744 |
| 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
Type 5, House No. 404, AIIMS Kalyani, Basantapur, Nadia District West Bengal
Nadia
WEST BENGAL
741245
India |
| Phone |
9818039744 |
| Fax |
|
| Email |
poonam.nursing@aiimskalyani.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
other self |
| Address |
Room No. 401, 4th Floor, College of Nursing, AIIMS Kalyani, 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 |
3rd Floor of College of Nursing, AIIMS Kalyani
Nadia
WEST BENGAL |
9818039744
033-29991580
poonam.nursing@aiimskalyani.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMS kalyani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
1 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional CPR method |
CPR will be taught using the normal manikins not giving feedback |
| Intervention |
CPR Training using QCPR mannikin |
training will be provided to the participants on a manikin which will provide feedback to the participants |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Female |
| Details |
available during study
willing to participate
giving written informed consent |
|
| ExclusionCriteria |
| Details |
not able to participate due to medical condition |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Depth of chest compression |
at baseline and immeidately after intervention |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/05/2025 |
| 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="4" |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [poonam.nursing@aiimskalyani.edu.in].
- For how long will this data be available start date provided 01-10-2025 and end date provided 31-12-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIl
|
|
Brief Summary
|
in this RCT, nursing students will be randomized to intervention and control groups. Intervention group will receive cardiopulmonary resuscitation training on a manikin which is able to give the feedback and control group will receive the training using the ordinary manikin. The post intervention assessment in terms of compression depth will be done next day for all the students using the manikin having the feedback device. |