FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/05/087095 [Registered on: 20/05/2025] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Behavioral 
Study Design  Other 
Public Title of Study   Simulation study in ward conditions before and after use of CPR feedback device  
Scientific Title of Study   In-situ simulation for assessment of CPR feedback device use for BLS skills in trained CPR providers: A pre-post intervention study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AMIT Kumar 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no. 4, Porta cabin, 5th floor, Teaching block, All India Institute of Medical Sciences, New Delhi
Room no. 4, Porta cabin, 5th floor, Teaching block, All India Institute of Medical Sciences, New Delhi
South West
DELHI
110029
India 
Phone  8055087505  
Fax    
Email  amit2007kr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  AMIT Kumar 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no. 4, Porta cabin, 5th floor, Teaching block, All India Institute of Medical Sciences, New Delhi
Room no. 4, Porta cabin, 5th floor, Teaching block, All India Institute of Medical Sciences, New Delhi
South West
DELHI
110029
India 
Phone  8055087505  
Fax    
Email  amit2007kr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  AMIT Kumar 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no. 4, Porta cabin, 5th floor, Teaching block, All India Institute of Medical Sciences, New Delhi
Room no. 4, Porta cabin, 5th floor, Teaching block, All India Institute of Medical Sciences, New Delhi
South West
DELHI
110029
India 
Phone  8055087505  
Fax    
Email  amit2007kr@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of medical sciences, New Delhi (Intramural fund) 
 
Primary Sponsor  
Name  AIIMS (Intramural fund) 
Address  All India Institute of Medical Sciences, New Delhi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amit Kumar  All India Institute of Medical Sciences  All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
South West
DELHI 
8055087505

amit2007kr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institute Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Volunteer BLS trained providers able to perform chest compression 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CPR parameters assessment before the real time feedback device for BLS skills in trained CPR providers  This will be a pre-post intervention study, in which all the participants will participate in CPR code on a mannequin in in-situ settings without any feedback. Baseline chest compression metrics will be stored in digital form with the help of sensors of mannequin. Now, the participant will be demonstrated features and use of real time feedback device. The real-time feedback device will provide information on compression depth, compression rate and chest recoil. After the demonstration, the same participant will be asked to participate in CPR code with the use of real-time feedback device. Each participant will serve as their own control.  
Intervention  Use of real time feedback device for BLS skills in trained CPR providers  This will be a pre-post intervention study, in which all the participants will participate in CPR code on a mannequin in in-situ settings without any feedback. Baseline chest compression metrics will be stored in digital form with the help of sensors of mannequin. Now, the participant will be demonstrated features and use of real time feedback device. The real-time feedback device will provide information on compression depth, compression rate and chest recoil. After the demonstration, the same participant will be asked to participate in CPR code with the use of real-time feedback device. Each participant will serve as their own control.  
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  65.00 Day(s)
Gender  Both 
Details  1. Experienced CPR providers (Resident doctors, nurses, technicians etc) who have undergone a structured CPR training program.
2. Participants willing to take part in the study
 
 
ExclusionCriteria 
Details  1. Participant refusal
2. Inability to perform CPR on mannequin for continuous 2 minutes.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate compliance with ideal CPR compression metrics with the help of composite CPR variable “Excellent CPR” defined as achieving at least 90% compliance with the chest compression depth, rate of compression and chest recoil before and after the introduction of real time feedback device for each participant.   The participants will be evaluated during the simulation exercise on the day of conduct of the exercise.  
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of chest compressions compliant with AHA high quality chest compression metrics in the study.  The participants will be evaluated during the simulation exercise on the day of conduct of the exercise.  
The participants subjective satisfaction score of the usefulness of realtime feedback on fivepoint Likert scale.  The participants will be evaluated during the simulation exercise on the day of conduct of the exercise.  
The participants ease of use score on five-point Likert scale.  The participants will be evaluated during the simulation exercise on the day of conduct of the exercise. 
To calculate chest compression fraction.   The participants will be evaluated during the simulation exercise on the day of conduct of the exercise. 
 
Target Sample Size   Total Sample Size="61"
Sample Size from India="61" 
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 4 
Date of First Enrollment (India)   10/06/2025 
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="2"
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  

Worldwide, cardiac arrest is a leading cause of death, and survival rates are still poor, particularly in low- and middle-income nations like India. Cardiopulmonary resuscitation (CPR) is a vital procedure that can raise a patient’s chance of survival after a cardiac arrest. However, the level of CPR performed by medical personnel can vary greatly, and factors including fatigue, stress, and inadequate training can all result in less-than-ideal results. As they can offer input on crucial performance characteristics including compression rate, depth, and breathing volume, real-time feedback devices have been proposed as a viable technique to enhance CPR quality.

Real-time feedback devices have been found to improve CPR quality but their adoption in clinical practice is still in its infancy. There is a need to assess real-time feedback device’s efficacy in the clinical context given the paucity of data on CPR and the potential advantages of such devices. The proposed study intends to evaluate the effects of real-time feedback device on CPR performance among experienced CPR providers (Resident doctors, nurses, technicians etc) in a mannequin-based in-situ CPR code settings. Future CPR training programs may benefit from the study’s insights into how real-time feedback is viewed to be valuable by CPR practitioners. The results of this study could have a big impact on how well CPR is done and how patients do in India and other places with similar conditions.

 

 
Close