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, 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).

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 (4)

• Survival to hospital admission

  1 day

• One year survival

  1 year

• Survival with good neurologic outcome at discharge

  30 days

• Survival with complete neurologically outcome

  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 18 or younger
• Collapse is not witnessed
• Bystander has never been taught CPR. (These bystanders should be instructed to administer CO-CPR in accordance to guidelines)
• Asphyxia, i.e. drowning, strangulation, hanging
• Intoxication or drug overdose
• Pregnancy
• Trauma
• Previous decision that CPR should not be initiated i.e. terminal illness or palliative care
• No Cardiac arrest, other condition (Cases where EMS did not start CPR)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Swedish Heart Lung Foundation: collaborator
• The Swedish Research Council: 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, Department of Medicine Solna

  PRINCIPAL INVESTIGATOR

• Giuseppe Ristagno, MD, PhD

  University of Milan

  STUDY CHAIR

Central Study Contacts

Erik Boberg, MD

CONTACT

0046735992842; erik.b.boberg@ki.se

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 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.
• 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: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); IT (1)