| CTRI Number |
CTRI/2026/03/105562 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing a machine that gives automatic chest compressions with manual chest compressions in patients with cardiac arrest in the emergency department. |
|
Scientific Title of Study
|
COMPARISON OF MECHANICAL WITH MANUAL
CARDIOPULMONARY RESUSCITATION IN CARDIAC ARREST
PATIENTS IN EMERGENCY DEPARTMENT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRVIVEK |
| Designation |
POST GRADUATE |
| Affiliation |
A.B.V.I.M.S AND DR.RML HOSPITAL |
| Address |
ROOM NO. 18 OLD EMERGENCY BUILDING DEPARTMENT OF EMERGENCY MEDICINE Baba Kharak Singh Rd near Gurudwara Bangla Sahib Ram Manohar Lohia Hospital Type III Connaught Place New Delhi Delhi 110001
Baba Kharak Singh Rd near Gurudwara Bangla Sahib Ram Manohar Lohia Hospital Type III Connaught Place New Delhi Delhi 110001
New Delhi
DELHI
110001
India |
| Phone |
9996885995 |
| Fax |
|
| Email |
DR.VIVEK1097@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HIMANSHU SIKRI |
| Designation |
SPECIALIST CGHS SENIOR CONSULTANT NBEMS |
| Affiliation |
A.B.V.I.M.S AND DR.RML HOSPITAL |
| Address |
ROOM NO. 18 OLD EMERGENCY BUILDING DEPARTMENT OF EMERGENCY MEDICINE Baba Kharak Singh Rd near Gurudwara Bangla Sahib Ram Manohar Lohia Hospital Type III Connaught Place New Delhi Delhi 110001
Baba Kharak Singh Rd near Gurudwara Bangla Sahib Ram Manohar Lohia Hospital Type III Connaught Place New Delhi Delhi 110001
New Delhi
DELHI
110001
India |
| Phone |
9996885995 |
| Fax |
|
| Email |
drhimanshusikri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DRVIVEK |
| Designation |
POST GRADUATE |
| Affiliation |
A.B.V.I.M.S AND DR.RML HOSPITAL |
| Address |
ROOM NO. 18 OLD EMERGENCY BUILDING DEPARTMENT OF EMERGENCY MEDICINE Baba Kharak Singh Rd near Gurudwara Bangla Sahib Ram Manohar Lohia Hospital Type III Connaught Place New Delhi Delhi 110001
Baba Kharak Singh Rd near Gurudwara Bangla Sahib Ram Manohar Lohia Hospital Type III Connaught Place New Delhi Delhi 110001
New Delhi
DELHI
110001
India |
| Phone |
9996885995 |
| Fax |
|
| Email |
DR.VIVEK1097@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ABVIMS AND DR.RML HOSPITAL |
| Address |
Baba Kharak Singh Rd near Gurudwara Bangla Sahib Ram Manohar Lohia Hospital Type III Connaught Place New Delhi Delhi 110001 |
| 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 |
| DRVIVEK |
ABVIMS AND DR.RML HOSPITAL |
ROOM NO. 18 OLD EMERGENCY BUILDING DEPARTMENT OF EMERGENCY MEDICINE Baba Kharak Singh Rd near Gurudwara Bangla Sahib Ram Manohar Lohia Hospital Type III Connaught Place New Delhi Delhi 110001
New Delhi
DELHI |
9996885995
DR.VIVEK1097@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional_ethics_comittee_ABVIMS_DrRMLHospital_NewDelhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I469||Cardiac arrest, cause unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MECHANICAL CPR |
CARDIO PULMONARY RESUSCITATION BY AUTOPULSE DEVICE |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
adults patients more than 18 years of age
non traumatic cardiac arrest |
|
| ExclusionCriteria |
| Details |
1. Patients with known Do Not Resuscitate status.
2. Pregnant patients.
3. Prisoner patients and medico-legal case.
4. Patients who previously received either mechanical or manual cardio-pulmonary resuscitation before presenting to emergency.
5.Trauma patients with cardiac arrest.
6. Patient does not fit into the mechanical cardio-pulmonary resuscitation device
7 No trained staff in the deployment of a mechanical cardio-pulmonary resuscitation device in attendance. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare the return of spontaneous circulation (ROSC) in mechanical with
manual cardio-pulmonary resuscitation in adult cardiac arrest patients in
emergency department. |
1.TIME TAKEN 10 MINUTES 20 MINUTES
2.30 Days outcome
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare time taken to achieve Return of spontaneous circulation in mechanical
with manual cardio-pulmonary resuscitation.
2. To compare the 30 days Survival in mechanical with manual cardio-pulmonary
resuscitation. |
1. To compare time taken to achieve Return of spontaneous circulation in mechanical
with manual cardio-pulmonary resuscitation.
2. To compare the 30 days Survival in mechanical with manual cardio-pulmonary
resuscitation. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
03/04/2026 |
| 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 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
|
This study aims to compare the effectiveness of mechanical cardiopulmonary resuscitation with manual cardiopulmonary resuscitation in patients presenting with cardiac arrest in the emergency department. High quality chest compressions are essential for improving survival in cardiac arrest. Manual cardiopulmonary resuscitation may vary depending on rescuer fatigue and technique, whereas mechanical devices provide automated and consistent chest compressions.
The objective of this study is to evaluate return of spontaneous circulation, survival outcomes, and immediate clinical parameters in patients receiving mechanical versus manual cardiopulmonary resuscitation. This study will be conducted in the emergency department of a tertiary care hospital. Eligible adult patients with cardiac arrest will be included as per predefined criteria.
The findings of this study may help determine whether mechanical cardiopulmonary resuscitation offers any clinical advantage over conventional manual cardiopulmonary resuscitation in emergency settings and may guide future resuscitation practices. |