Compression Only CPR Versus Standard CPR in Out-Of-Hospital Cardiac Arrest - A Randomized Survival Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet

About this trial

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, or even superior to standard CPR in situations where the bystander has previous CPR training remains unclear. This clinical question remains unanswered while millions of people are trained in CPR worldwide each year.

To investigate whether CO-CPR is non-inferior to standard CPR (S-CPR) when performed by a bystander with previous CPR training in witnessed, non-asphyxic cases of OHCA. Superiority testing will also be performed for the purpose of demonstrating a possible increase in survival with CO-CPR.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Unconsciousness with no, abnormal or agonal breathing (suspected OHCA)

The suspected OHCA is witnessed (seen or heard)

Any Bystander at the scene has previous training in CPR

Disqualifiers

Age below 18 years

Collapse is not witnessed

Bystander has no prior CPR training

Obvious asphyxia (i.e. hanging, foreign body, suffocation, strangulation)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chest Compression Only CPR (CO-CPR) performed by trained bystanders after instructions from dispatchers

    Other intervention

    Instructions by dispatcher to bystander to provide CPR with chest-compressions only The instructions from the dispatcher in interventional arm include: * An ambulance is dispatched and is on it´s way to you * Do CPR with chest compressions only * Push hard on the chest with a pace of 100/minute without interruptions for rescue breathing.

  • Standard CPR (S-CPR) performed by trained bystanders after instructions from dispatchers

    Other intervention

    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: * An ambulance is dispatched and is on it´s way to you * Do CPR with chest compressions and rescue breathing * Push hard on the chest 30 times and give 2 rescue breaths. The pace of the compressions should be 100/minute.

Treatment groups

3,260 Participants
are divided into 2 treatment groups
Group A: Chest Compression Only CPR (CO-CPR)Experimental treatment 1 intervention
Group B: Standard CPR (S-CPR)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

30-day survival

Survival to 30 days after cardiac arrest

Time frame
1 month

Secondary outcomes

1

1-day survival

1-day survival will be derived from the date of death recorded in Swedish Cardiopulmonary Resuscitation Registry (SRCR). Because SRCR only provides the calendar date of death (and not the exact time), we cannot reliably determine the Utstein variable "survival to hospital admission". We therefore will use 1-day survival as a proxy. If the SRCR date of death is the calendar day after the event date, the patient will be classified as still alive after 1-day. Separating survival to hospital admission from early in-hospital death will not be possible with the available SRCR data.

Time frame
1 day
2

1-year survival

Survival to 1-year after cardiac arrest

Time frame
1 year
3

Survival with good neurologic outcome at discharge

Survival to hospital discharge with cerebral performance category (CPC) 1-2

Time frame
30 days

Other outcomes

1

Proportion of participants found with VT/VF at first rhythm analysis

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)

Time frame
1 day
2

Proportion of participants with return of spontaneous Circulation (ROSC)

Proportion of participants with return of spontaneous Circulation

Time frame
1 day
3

Analysis of primary endpoint (30-day survival) in pre-defined subgroup

Subgroups will be analysed according to the following pre-defined variables: Sex, Age, Cause of OHCA, Initial rhythm, Location of cardiac arrest, Time to start of bystadner CPR, Time to arrival of EMS and Neurological severity classification (CPC).

Time frame
30 days

Sponsors and contacts

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Karolinska Institutet

Lead sponsor

Swedish Heart Lung Foundation

Collaborator

SOS Alarm

Collaborator

Azienda Regionale Emergenza Urgenza - AREU Lombardia

Collaborator

The Swedish Research Council

Collaborator