| CTRI Number |
CTRI/2013/07/003840 [Registered on: 25/07/2013] Trial Registered Retrospectively |
| Last Modified On: |
25/07/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of manual cardiopulmonary Resusciatation with resuscitation using a mechanical device(AutoPulse®)in patients with in-hospital cardiac arrest |
|
Scientific Title of Study
|
Randomised comparison of chest compression using the device AutoPulse® with manual chest compressions in patients requiring Cardiopulmonary Resuscitation (CPR) for in hospital cardiac arrest. |
| Trial Acronym |
CAPCAR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1139-5152 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Syed Moied Ahmed |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesia
Jawaharlal Nehru Medical College, Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897454739 |
| Fax |
|
| Email |
sma99@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Azharuddin Mohammed Malik |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Medicine
Jawaharlal Nehru Medical College, Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8126320218 |
| Fax |
|
| Email |
malikazharuddin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Azharuddin Mohammed Malik |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Medicine
Jawaharlal Nehru Medical College, Aligarh Muslim University
Barabanki
UTTAR PRADESH
202002
India |
| Phone |
8126320218 |
| Fax |
|
| Email |
malikazharuddin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Investigator Initiated and Funded |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesia |
| Address |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| 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 Syed Moied Ahmad |
J.N.Medical College and Hospital |
Dr Syed Moied Ahmad
Department of anesthesia,Near OT Complex,J.N.Medical College and Hospital.
Aligarh
UTTAR PRADESH |
9897454739
sma99@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, J.N. Medical College, Aligarh Muslim University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cardiac Arrest, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AutoPulse® |
Mechanical chest compression Device. It will provide chest compression at 100/mins for the duration of resuscitation |
| Comparator Agent |
Manual CPR |
CPR will be done utilising conventional manual chest compression with hands with targeted rate at least 100/mins for the duration of resuscitation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with cardiac arrest in emergency department. |
|
| ExclusionCriteria |
| Details |
1. Age < 18 years.
2. Cardiac arrest patients with chest trauma.
3. Patient already on Advanced life Support
4. Patients achieving ROSC after the initial 5 mins of manual CPR according to the 2010 guidelines.
5. Predicted Futile Resuscitation based on fixed dilated pupils, GCS3/15, absent pupillary and other brain stem reflexes in the absence of drug intoxications.
6. Pregnant females
7. Patients with Do Not Resuscitate (DNR) orders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Efficacy Endpoints:
1. Sustained Return of Spontaneous Circulation (ROSC): admission to ICU/wards with a palpable pulse and measurable BP.
2. Overall survival
3. Survival to 24 hrs: being alive 24hrs after the initial arrest.
4. Survival to hospital discharge: discharge to home or a chronic care facility
|
1. at 24 hours
2. Hospital discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Efficacy Endpoints:
1. In patients with survival to discharge
a. Modified Rankin Scale
b. Cerebral Performance Category
2. APACHE III Score |
Survival at 24 hrs and at discharge. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/06/2013 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Continuous chest
compressions are an important and indispensable part of cardiopulmonary
resuscitation (CPR) and has been shown to enhance survival. However the quality of the chest compressions provided by the rescuer
is often variable and not only depends on the physical built of the rescuer but
also on the positioning of the patient. Also the quality of the chest compressions decline with increasing
time of CPR, often requiring change of rescuer every 2 minutes. The AutoPulse® Resuscitation System (ZOLL Circulation) is a battery
operated load distributing band (LDB) circumferential chest compression device. AutoPulse® provides mechanical chest compressions utilizing an electrically
actuated constricting band on a short backboard. Although it has been mentioned
in the CPR 2010 guidelines, but data regarding its usefulness in CPR is still equivocal. Therefore we propose an investigator initiated randomised comparison
of mechanically assisted CPR using AutoPulse® (A-CPR) with conventional CPR
involving manual chest compressions (M-CPR). |