The key technology and standard of mechanical circulatory support
| ISRCTN | ISRCTN14218569 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14218569 |
| Secondary identifying numbers | N/A |
- Submission date
- 21/03/2015
- Registration date
- 27/04/2015
- Last edited
- 27/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
150 Haping Street
Nangang District
Harbin
150081
China
 ORCID ID |
0000-0003-3365-1988 |
|---|
Study information
| Study design | Multicenter prospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Prospective observational study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A multicenter study on the standardized application of mechanical cardiopulmonary resuscitation in patients with cardiac arrest |
| Study objectives | To evaluate the efficacy of mechanical cardiopulmonary resuscitation in critical patients with cardiac arrest. |
| Ethics approval(s) | Medical Ethics Committee of the Second Affiliated Hospital of Harbin Medical University, 10/05/2013 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/03/2013 |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 160 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2013 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- China
Study participating centres
Sponsor information
Government
Beijing city
Xicheng District
1 Xizhimenwainan Road
Bejing
100044
China
"ROR" |
https://ror.org/052eegr76 |
|---|
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Ministry of Health of China, National Health and Family Planning Commission, Chinese Health and Family Planning Committee
- Location
- China
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We intend to publish our study in the future. We are analyzing the data now. |
| IPD sharing plan |
