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

NCT03981107 | Recruiting DMC

• 1 other identifier: NCT3
• Study Type: interventional
• Target: 3,260
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Out-Of-Hospital Cardiac Arrest; Cardiac Arrest; Cardiopulmonary Resuscitation

Keywords

Cardiopulmonary Resuscitation; Chest compressions only CPR; Dispatcher assisted CPR; Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• 30-day survival

  Survival to 30 days after cardiac arrest

  1 month

Secondary Outcomes (3)

• 1-day survival

  1 day

• 1-year survival

  1 year

• Survival with good neurologic outcome at discharge

  30 days

Other Outcomes (3)

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

  1 day

• Proportion of participants with return of spontaneous Circulation (ROSC)

  1 day

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

  30 days

Study Arms (2)

Chest Compression Only CPR (CO-CPR)

EXPERIMENTAL

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

Standard CPR (S-CPR)

ACTIVE COMPARATOR

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

Interventions

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

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.

Also known as: Chest compression only CPR, Compression only CPR, Hands-only CPR

Chest Compression Only CPR (CO-CPR)

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

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.

Also known as: Standard CPR

Standard CPR (S-CPR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Not EMS-verified cardiac arrest
• Previous do not resuscitate (DNR) decision

Sponsors & Collaborators

• The Swedish Research Council: collaborator
• Karolinska Institutet: lead
• Swedish Heart Lung Foundation: collaborator
• SOS Alarm: collaborator
• Azienda Regionale Emergenza Urgenza - AREU Lombardia: collaborator

Study Sites (2)

AREU, Agenzia Regionale Emergenza Urgenza

Bergamo, Italy

RECRUITING

SOS Alarm AB

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jacob Hollenberg, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Giuseppe Ristagno, MD, PhD

  University of Milan

  STUDY CHAIR

• Gabril Riva, MD, PhD

  Karolinska Institutet

  STUDY CHAIR

• Martin Jonsson, McS, PhD

  Karolinska Institutet

  STUDY CHAIR

• Mattias Ringh, MD, PhD

  Karolinska Institutet

  STUDY CHAIR

• Per Nordberg, MD, PhD

  Karolinska Institutet

  STUDY CHAIR

• Annette Nord, RN, PhD

  Karolinska Institutet

  STUDY CHAIR

• Andreas Claesson, RN, PhD

  Karolinska Institutet

  STUDY CHAIR

• Marcus Skrifvars, MD, PhD

  University of Helsinki

  STUDY CHAIR

Central Study Contacts

Jacob Hollenberg, MD. PhD

CONTACT

004686163816; jacob.hollenberg@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Because of the inherent logistical problems, where the dispatcher at the emergency medical dispatch center can not be blinded to the randomized allocation (instruction), the study is defined as open-label. Treatment allocation will, however, be blinded for EMS, data management, and at follow-up, for clinicians treating the patients at the hospitals, and for all responsible researchers. Allocation concealment will be preserved.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of research - Centre For Resuscitation Science.

Model Details: Randomized, 1:1, open-label, multicenter trial

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 10, 2019
• Study Start: January 1, 2017
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); IT (1)