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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
Sponsor:
Collaborators:
Swedish Heart Lung Foundation
The Swedish Research Council
SOS Alarm
Information provided by (Responsible Party):
Jacob Hollenberg, Karolinska Institutet

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).


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3260 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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:

  • 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.
Other Names:
  • Chest compression only CPR
  • Compression only CPR
  • Hands-only CPR

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:

  • 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.
Other Name: Standard CPR




Primary Outcome Measures :
  1. 30-day survival [ Time Frame: 1 month ]
    Survival to 30 days after cardiac arrest


Secondary Outcome Measures :
  1. Survival to hospital admission [ Time Frame: 1 day ]
    Survival to admission to hospital

  2. One year survival [ Time Frame: 1 year ]
    Survival to one year after cardiac arrest

  3. Survival with good neurologic outcome at discharge [ Time Frame: 30 days ]
    Survival to hospital discharge with cerebral performance category (CPC) 1-2

  4. Survival with complete neurologically outcome [ Time Frame: 30 days ]
    Survival to hospital discharge with cerebral performance category (CPC) 1


Other Outcome Measures:
  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)

  2. Proportion of participants with return of spontaneous Circulation (ROSC) [ Time Frame: 1 day ]
    Proportion of participants with return of spontaneous Circulation

  3. 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:

    • Gender
    • Age
    • 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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

Post randomisation exclusion Criteria from data analysis:

  • 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)

Information from the National Library of Medicine

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


Contacts
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Contact: Gabriel Riva, MD 0046705452086 gabriel.riva@ki.se
Contact: Jacob Hollenberg, MD, PhD 004686163816 Jacob.hollenberg@ki.se

Locations
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Sweden
SOS Alarm AB Recruiting
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Swedish Heart Lung Foundation
The Swedish Research Council
SOS Alarm
Investigators
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Principal Investigator: Jacob Hollenberg, MD, PhD Karolinska Institutet, Department of Medicine Solna
  Study Documents (Full-Text)

Documents provided by Jacob Hollenberg, Karolinska Institutet:

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Responsible Party: Jacob Hollenberg, Associate Professor, Head of research - Centre For Resuscitation Science., Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03981107     History of Changes
Other Study ID Numbers: NCT3
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be published on group level only

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jacob Hollenberg, Karolinska Institutet:
Cardiopulmonary Resuscitation
Chest compressions only CPR
Dispatcher assisted CPR
Cardiac Arrest

Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases