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Clinical Trials in Italy / NCT03981107
Recruiting Not applicable

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

NCT03981107 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2017-01-01
Last updated
2026-05-08

Condition(s) studied

Out-Of-Hospital Cardiac ArrestCardiac ArrestCardiopulmonary Resuscitation

Investigational drug(s) / intervention(s)

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

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: * 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: 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.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * Age below 18 years * Collapse is not witnessed * Bystander has no prior CPR training * Obvious asphyxia (i.e. hanging, foreign body, suffocation, strangulation) * Obvious drug overdose / intoxication * Pregnancy * Trauma (penetrating, blunt, burn injury) Post randomisation exclusion Criteria from data analysis: * Not EMS-verified cardiac arrest * Previous do not resuscitate (DNR) decision

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
AREU, Agenzia Regionale Emergenza Urgenza Bergamo Italy Recruiting
SOS Alarm AB Stockholm Sweden Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03981107 on ClinicalTrials.gov ↗ ← All trials in Italy