Compression Only CPR Versus Standard CPR in Out-Of-Hospital Cardiac Arrest - A Randomized Survival Study (TANGO2)
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|ClinicalTrials.gov Identifier: NCT03981107|
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : June 12, 2019
Out-of-hospital cardiac arrest (OHCA) is one of the leading causes of mortality in the industrialized world. Bystander CPR before arrival of the Emergency Medical Service (EMS) is associated with an increased chance of survival. During the last decade, the best form of bystander CPR has been debated. Chest Compression Only CPR (CO-CPR) has been advocated as a preferable method in situations where the bystander has no previous knowledge in CPR, both because its believed to be equally efficient but also a simplified form of CPR that could lead to a higher incidence of bystander-CPR.
In an initiative to increase CPR rates the American Heart Association has launched public campaigns such as the "hands-only CPR" promoting CO-CPR as an option to S-CPR for adult non-asphyxic cardiac arrest. In the 2015 updates of the European resuscitation council guidelines it states that the confidence in the equivalence between the two methods is not sufficient to change current practice.
Whether CO-CPR leads to a survival rate no worse than, equally effective, or even superior to standard CPR in situations where the bystander has previous CPR training however remains unclear. This clinical question remains unanswered while millions of people are trained in CPR worldwide each year.
The overall purpose with this research project is to investigate whether instructions to perform a simplified form of CPR consisting of compressions only (CO-CPR) to bystanders with prior CPR-training is non-inferior, or better than, standard CPR (S- CPR) in witnessed Out-of-Hospital Cardiac Arrest (OHCA).
|Condition or disease||Intervention/treatment||Phase|
|Out-Of-Hospital Cardiac Arrest Cardiac Arrest Cardiopulmonary Resuscitation||Other: Chest Compression Only CPR (CO-CPR) performed by trained bystanders after instructions from dispatchers Other: Standard CPR (S-CPR) performed by trained bystanders after instructions from dispatchers||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3260 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, 1:1, open label, multicenter trial|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Because of the inherent logistical problems with blinding of CPR techniques for dispatchers, the trial is considered as an "open labeled" trial. Treatment allocation will, however, be blinded in data management and at follow-up, for personnel treating the patients at the hospitals and for all responsible researchers. Allocation concealment will be preserved.|
|Official Title:||A Randomized Trial Comparing Survival After of a Simplified Form of Cardiopulmonary Resuscitation (CPR) Consisting of Compressions Only Compared to CPR With Compressions and Rescue Breaths|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2024|
Experimental: Chest Compression Only CPR (CO-CPR)
Instructions from a dispatcher at the dispatch center to trained bystanders to perform CO-CPR with chest compressions only.
Other: Chest Compression Only CPR (CO-CPR) performed by trained bystanders after instructions from dispatchers
Instructions by dispatcher to bystander to provide CPR with chest-compressions only
The instructions from the dispatcher in interventional arm include:
Active Comparator: Standard CPR (S-CPR)
Instructions from a dispatcher at the dispatch center to trained bystanders to perform S-CPR with chest compressions and rescue breaths in a 30:2 ratio.
Other: Standard CPR (S-CPR) performed by trained bystanders after instructions from dispatchers
Instructions by dispatcher to bystander to provide CPR with chest-compressions and rescue breaths in a ration of 30:2
The Instructions from the dispatcher in the control arm include:
Other Name: Standard CPR
- 30-day survival [ Time Frame: 1 month ]Survival to 30 days after cardiac arrest
- Survival to hospital admission [ Time Frame: 1 day ]Survival to admission to hospital
- One year survival [ Time Frame: 1 year ]Survival to one year after cardiac arrest
- Survival with good neurologic outcome at discharge [ Time Frame: 30 days ]Survival to hospital discharge with cerebral performance category (CPC) 1-2
- Survival with complete neurologically outcome [ Time Frame: 30 days ]Survival to hospital discharge with cerebral performance category (CPC) 1
- Proportion of participants found with VT/VF at first rhythm analysis [ Time Frame: 1 day ]Proportion of participants found with Ventricular tachycardia (VT) or ventricular fibrillation (VF) at first rhythm analysis by the EMS or by an automated external defibrillator (AED)
- Proportion of participants with return of spontaneous Circulation (ROSC) [ Time Frame: 1 day ]Proportion of participants with return of spontaneous Circulation
- Analysis of primary endpoint (30-day survival) in pre-defined subgroup [ Time Frame: 30 days ]
Proportion of patients surviving to 30 days after cardiac arrest in subgroups stratified by:
- Cardiac vs non-cardiac cause of OHCA
- Time to start of CPR
- Patients with initial shockable rhythm vs initial non-shockable rhythm
- Call to arrival time of EMS
- Place of cardiac arrest (at home vs outside home)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981107
|Contact: Gabriel Riva, MDemail@example.com|
|Contact: Jacob Hollenberg, MD, PhD||004686163816||Jacob.firstname.lastname@example.org|
|SOS Alarm AB||Recruiting|
|Principal Investigator:||Jacob Hollenberg, MD, PhD||Karolinska Institutet, Department of Medicine Solna|