Condition category
Circulatory System
Date applied
21/03/2015
Date assigned
27/04/2015
Last edited
27/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A cardiac arrest happens when your heart stops pumping blood around the body. Cardiopulmonary resuscitation is then performed to keep blood and oxygen circulating in the body. Cardiopulmonary resuscitation machines have replaced manual cardiopulmonary resuscitation in many hospitals. However, there is not enough evidence to support or refute the routine use of mechanical cardiopulmonary resuscitation in the treatment of cardiac arrest. The aim of this study is to evaluate the effectiveness of mechanical cardiopulmonary resuscitation in critical patients with cardiac arrest.

Who can participate?
Men or women aged over 18 with cardiac arrest.

What does the study involve?
Participants in the test group were treated with mechanical cardiopulmonary resuscitation; participants in the control group were treated with manual cardiopulmonary resuscitation.

What are the possible benefits and risks of participating?
The possible benefit of participating is a better prognosis. The possible risk of participating is rib fracture.

Where is the study run from?
1. The Second Affiliated Hospital of Harbin Medical University
2. West China Hospital of Sichuan University
3. Sichuan Provincial People's Hospital
4. Zhongnan Hospital of Wuhan University
5. The First Affiliated Hospital of Xi'an Jiaotong University
6. Zhejiang Hospital
7. The First Affiliated Hospital of China Medical University
8. The First Affiliated Hospital of Zhongshan University

When is the study starting and how long is it expected to run for?
From March to December 2013.

Who is funding the study?
National Health and Family Planning Commission of the People's Republic of China.

Who is the main contact?
Dr KaiJiang Yu

Trial website

Contact information

Type

Scientific

Primary contact

Dr KaiJiang Yu

ORCID ID

http://orcid.org/0000-0003-3365-1988

Contact details

150 Haping Street
Nangang District
Harbin
150081
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A multicenter study on the standardized application of mechanical cardiopulmonary resuscitation in patients with cardiac arrest

Acronym

Study hypothesis

To evaluate the efficacy of mechanical cardiopulmonary resuscitation in critical patients with cardiac arrest.

Ethics approval

Medical Ethics Committee of the Second Affiliated Hospital of Harbin Medical University, 10/05/2013

Study design

Multicenter prospective observational study

Primary study design

Observational

Secondary study design

Prospective observational study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cardiac arrest

Intervention

From 01/03/2013 to 15/07/2013 patients with cardiac arrest underwent manual cardiopulmonary resuscitation according to international guidelines (control group). The CPR machine was introduced in our ICU in July 2013. Doctors and nurses in our ICU were trained how to use the CPR machine from 16/07/2013 to 15/08/2013. From 16/08/2013 to 31/12/2013 we used mechanical CPR devices for the treatment of cardiac arrest (test group).

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Survival rate for 4 hours after starting cardiopulmonary resuscitation

Secondary outcome measures

1. Survival to hospital discharge
2. Neurological status among survivors - cerebral performance category at 4, 24 , 48 and 72 hours after starting cardiopulmonary resuscitation

Overall trial start date

01/03/2013

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men or women included in each center during the study period aged more than 18 years
2. First occurrence of cardiac arrest in the ICU, or transferred to the ICU after the first occurrence of cardiac arrest
3. Cardiac arrest must be less than 30 minutes before cardiopulmonary resuscitation in the ICU

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. No resuscitation attempts with the cardiac arrest occurred for more than 3 minutes
2. Unable to carry out chest compressions (such as serious rib injury)
3. Cardiac arrest after thoracic surgical operation
4. Low temperature, poisoning, drowning or hanging caused the cardiac arrest
5. Mentally disabled
6. Pregnant women

Recruitment start date

01/03/2013

Recruitment end date

31/12/2013

Locations

Countries of recruitment

China

Trial participating centre

The Second Affiliated Hospital of Harbin Medical University
China

Trial participating centre

West China Hospital of Sichuan University
China

Trial participating centre

Sichuan Provincial People's Hospital
China

Trial participating centre

Zhongnan Hospital of Wuhan University
China

Trial participating centre

The First Affiliated Hospital of Xi'an Jiaotong University
China

Trial participating centre

Zhejiang Hospital
China

Trial participating centre

The First Affiliated Hospital of China Medical University
China

Trial participating centre

The First Affiliated Hospital of Zhongshan University
China

Sponsor information

Organisation

National Health and Family Planning Commission of the People's Republic of China

Sponsor details

Beijing city
Xicheng District
1 Xizhimenwainan Road
Bejing
100044
China

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Health and Family Planning Commission of the People's Republic of China

Alternative name(s)

Ministry of Health of China

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

China

Results and Publications

Publication and dissemination plan

We intend to publish our study in the future. We are analyzing the data now.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes