| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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. |
|
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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. | |