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Compression Only-CPR Versus Standard-CPR (TANGO2)

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ClinicalTrials.gov Identifier: NCT02401633
Recruitment Status : Completed
First Posted : March 30, 2015
Last Update Posted : September 19, 2022
Swedish Heart Lung Foundation
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 a positive predictor 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.

The purpose of this study is to perform av run-in period with focus on safety and feasibility prior to the launch of a larger randomized trial which has a primary end-point of survival. This study will compare OHCA with standard CPR (S-CPR; chest compressions and rescue breaths in a 30:2 fashion) compared to CO-CPR.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Out of Hospital Cardiac Arrest Procedure: CO-CPR Procedure: S-CPR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing the Effect of a Simplified Form of Cardiopulmonary Resuscitation (CPR) Consisting of Only Chest Compressions Compared to CPR With Compressions and Rescue Breaths - the PILOT
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : March 31, 2022
Actual Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CO-CPR Bystander
Instructions by dispatcher to trained bystander to provide CPR with chest-compressions only
Procedure: CO-CPR
CPR provided by bystander with chest-compressions only
Other Names:
  • Compression only CPR
  • Continous Chest Compressions

Active Comparator: S-CPR Bystander
Instructions by dispatcher to trained bystander to provide CPR with chest-compressions and rescue breaths in a 30:2 ratio
Procedure: S-CPR
CPR with Chest Compressions and Rescue Breaths in a ratio of 30:2
Other Name: Standard CPR

Primary Outcome Measures :
  1. Descriptive measurement of feasibility [ Time Frame: 6 months ]
    • Evaluation of automated inclusion and randomization
    • Evaluation of information of allocation to bystander
    • Adherence to the two protocol, bystanders (S-CPR/CO-CPR)
    • Validation of data collection and sources (please see appendix)
    • Sufficient inclusion of all OHCA during the RUN-IN study period

  2. Descriptive measurement of safety (delay CPR) [ Time Frame: 6 months ]
    • Delay to start of CPR due to screening for inclusion, exclusion, randomization and instructions to the witnesses (S-CPR/CO-CPR)
    • Correct inclusion
    • Correct exclusion
    • Proportion of patients correctly identified as cardiac arrests

Secondary Outcome Measures :
  1. Proportions of patients with ventricular fibrillation/ ventricular tachycardia (ITT and PP) [ Time Frame: within minutes from arrival of the EMS (day 1) ]
    Proportions of patients with ventricular fibrillation/ventricular tachycardia at first rhythm analysis

  2. Proportion of patients who achieve return of spontaneous circulation (ROSC) [ Time Frame: day 1 ]
    Proportion of patients who achieve return of spontaneous circulation (ROSC)

  3. Survival to hospital admission [ Time Frame: day 1 ]
    Survival to hospital admission

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

Inclusion Criteria:

  • Unconsciousness with no, abnormal or agonal breathing (suspected OHCA)
  • The suspected OHCA is witnessed (seen or heard)
  • Bystander has previous training in CPR

Exclusion Criteria:

  • Age 18 or younger
  • Collapse is not witnessed
  • Bystander has never been trained in CPR (these bystanders should be instructed to administer CO-CPR in accordance to guidelines).
  • Obvious asphyxia, i.e. drowning, strangulation, hanging
  • Obvious intoxication or drug overdose
  • Pregnancy
  • Obvious pregnancy
  • Trauma
  • Bystander is unwilling to participate or to perform 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): NCT02401633

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Stockholm, Sweden
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Swedish Heart Lung Foundation
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Principal Investigator: Jacob Hollenberg, MD, PhD Karolinska Institutet
  Study Documents (Full-Text)

Documents provided by Jacob Hollenberg, Karolinska Institutet:
Additional Information:
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Responsible Party: Jacob Hollenberg, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02401633    
Other Study ID Numbers: NCT
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: September 19, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be published on group level only
Keywords provided by Jacob Hollenberg, Karolinska Institutet:
Advanced Cardiac Life Support
Compression-Only CPR
Chest compression CPR
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases