Cardiac ArrestTANGO2NCT02401633
Compression Only-CPR Versus Standard-CPR
A study testing CO-CPR and S-CPR in people with Cardiac Arrest and Out of Hospital Cardiac Arrest, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Out of Hospital Cardiac Arrest
- What is being tested?
- CO-CPR and S-CPR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,250 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2017to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unconsciousness with no, abnormal or agonal breathing (suspected OHCA)
- The suspected OHCA is witnessed (seen or heard)
- Bystander has previous training in CPR
Who cannot join
- 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
Show all 9Show fewer
- Obvious pregnancy
- Trauma
- Bystander is unwilling to participate or to perform CPR
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Witnessed cases of OHCA with a non-asphyctic aetiology will be the principal study population. According to current guidelines an unresponsive patient with no or agonal breathing is treated as a suspected case of OHCA at the dispatch centre. These cases are eligible for screening for inclusion. If the case is witnessed, the bystander has previous knowledge in CPR and no exclusion criteria are present, the case can be included in the study.
The intervention consists of instructions from a dispatcher at the dispatch centre to bystanders to perform either CO-CPR (intervention) or S-CPR (control).
Instructions to bystanders on how to perform CO-CPR consists of continuous chest compressions without interruptions or rescue breaths. The instructions on how to perform S-CPR in the control group include information on giving chest compressions and rescue breaths in a 30:2 ratio (like current CPR recommendation state).
This is a national study were all dispatch centers in Sweden participate.
The overall study project is conducted in three different phases:
- Pre study RUN-IN period, for establishing logistical and technical study procedures (completed)
- PILOT STUDY, with focus feasibility, logistics and safety (Active, not recruting)
- MAIN STUDY will focus on 30 days survival (primary end point) and other important clinical outcomes (secondary outcomes)
Objective pre study RUN-IN period:
In order to test the technical inclusion procedures, logistics, feasibility and data collection a pre-study RUN-IN period started in Stockholm during 2015.
Objective PILOT study:
The aim of the PILOT study is to assess safety and feasibility of the TANGO2 trial design, as well as intermediate clinical outcomes. The TANGO2 trial started recruitment of patients on January 1st 2017 and last patient was included on December 31st 2018. All patients from the PILOT study will be included in the MAIN STUDY in a seamless design.
Objective MAIN study:
The aim of the MAIN study is to evaluate whether survival to 30 days following instructions to perform CO-CPR is non-inferior compared to instructions to perform S-CPR bystanders in witnessed OHCA where the bystander has previous CPR training. Secondary and exploratory objectives include the evaluation of neurological favorable survival, return of spontaneous circulation, admission to hospital, long-term survival and other clinical outcome variables as well as evaluations of 30-day survival between CO-CPR and S-CPR in pre-specified subgroups. The MAIN study will include patients from the PILOT phase in a seamless design
Experiences from the pre study RUN-IN period and implications for the PILOT and MAIN studies:
The pre-study RUN-IN period started in Stockholm County in 2015 and analysis were performed during 2016. After continuous technological adjustments, the randomization module was integrated within the computer aided dispatch system and was found to functioned well in the end of 2016. However, during pre-study RUN-IN period, one major obstacle was identified. Due to unexpected technological matters and an unanticipated new organization of the dispatch centers in Sweden only about 15% of the cardiac arrest calls for patients suffering cardiac arrest in Stockholm were actually answered by dispatchers in Stockholm; all other calls were transferred to other dispatch centers throughout Sweden. This meant that the dispatchers had to consider the geographical site of the suspected cardiac arrest and remember if that area was part of the study area. This new organization and logistics, were the call could be made in one area and answered and handled at another site and county during the pre-study RUN-IN period, resulted in a far greatly slower inclusion rate than anticipated and made a correct follow-up of patients unmanageable and unreliable. This made it impossible to conduct a PILOT study in Stockholm only.
As a consequence, a decision was made by the steering committee:
- To move the start of the PILOT study forward, until completion of the national expansion of the study and not to start inclusion of patients into the PILOT study before January 1st 2017. The new length of the PILOT study was set to two years to assure sufficient inclusion of patients to assess safety in terms of survival to hospital admission.
- That the PILOT study seamlessly will move on into the MAIN study in an inferentially seamless manner after the PILOT phase inclusion ended on Dec 31 2018. This means that patients from the PILOT study will also be included in the MAIN survival study. The outcomes for the PILOT study were changed to not interfere with the primary endpoint of the main survival study (30-day survival).
Inclusion and Exclusion criteria remained unchanged throughout the TANGO2-project.
- Conditions
- Cardiac Arrest, Out of Hospital Cardiac Arrest
- Being tested
- CO-CPR, S-CPR
- Keywords
- Cardio-Pulmonary-Resuscitation, Advanced Cardiac Life Support, Compression-Only CPR, Chest compression CPR
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO-CPRProcedure or surgery
Also called Compression only CPR, Continous Chest Compressions
CPR provided by bystander with chest-compressions only
S-CPRProcedure or surgery
Also called Standard CPR
CPR with Chest Compressions and Rescue Breaths in a ratio of 30:2
| Study group | Role | What they receive |
|---|---|---|
| CO-CPR Bystander | Experimental | Instructions by dispatcher to trained bystander to provide CPR with chest-compressions only Receives: Procedure: CO-CPR |
| S-CPR Bystander | Active comparator | Instructions by dispatcher to trained bystander to provide CPR with chest-compressions and rescue breaths in a 30:2 ratio Receives: Procedure: S-CPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive measurement of feasibility
- 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
Measured: 6 months
Descriptive measurement of safety (delay CPR)
- 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
Measured: 6 months
Secondary outcomes (3)
Proportions of patients with ventricular fibrillation/ ventricular tachycardia (ITT and PP)
Proportions of patients with ventricular fibrillation/ventricular tachycardia at first rhythm analysis
Measured: within minutes from arrival of the EMS (day 1)
Proportion of patients who achieve return of spontaneous circulation (ROSC)
Proportion of patients who achieve return of spontaneous circulation (ROSC)
Measured: day 1
Survival to hospital admission
Survival to hospital admission
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study start1 Jan 2017
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Heart Lung Foundation
- Responsible party
- Principal investigator, Jacob Hollenberg, Karolinska Institutet
- Investigators
- Jacob Hollenberg, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401633
- Sponsor's protocol ID
- NCT
- Acronym
- TANGO2
- Status last verified
- Sep 2022
- First submitted
- 7 Mar 2015
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be published on group level only
Publications
Riva G, Boberg E, Ringh M, Jonsson M, Claesson A, Nord A, Rubertsson S, Blomberg H, Nordberg P, Forsberg S, Rosenqvist M, Svensson L, Andrell C, Herlitz J, Hollenberg J. Compression-Only or Standard Cardiopulmonary Resuscitation for Trained Laypersons in Out-of-Hospital Cardiac Arrest: A Nationwide Randomized Trial in Sweden. Circ Cardiovasc Qual Outcomes. 2024 Mar;17(3):e010027. doi: 10.1161/CIRCOUTCOMES.122.010027. Epub 2024 Mar 6.
PubMed 38445487
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02401633
- Acronym / sponsor ID
- TANGO2 / NCT
- Conditions
- Cardiac Arrest, Out of Hospital Cardiac Arrest
- Keywords
- Cardio-Pulmonary-Resuscitation, Advanced Cardiac Life Support, Compression-Only CPR, Chest compression CPR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,250 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Swedish Heart Lung Foundation
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Witnessed cases of OHCA with a non-asphyctic aetiology will be the principal study population. According to current guidelines an unresponsive patient with no or agonal breathing is treated as a suspected case of OHCA at the dispatch centre. These cases are eligible for screening for inclusion. If the case is witnessed, the bystander has previous knowledge in CPR and no exclusion criteria are present, the case can be included in the study.
The intervention consists of instructions from a dispatcher at the dispatch centre to bystanders to perform either CO-CPR (intervention) or S-CPR (control).
Instructions to bystanders on how to perform CO-CPR consists of continuous chest compressions without interruptions or rescue breaths. The instructions on how to perform S-CPR in the control group include information on giving chest compressions and rescue breaths in a 30:2 ratio (like current CPR recommendation state).
This is a national study were all dispatch centers in Sweden participate.
The overall study project is conducted in three different phases:
- Pre study RUN-IN period, for establishing logistical and technical study procedures (completed)
- PILOT STUDY, with focus feasibility, logistics and safety (Active, not recruting)
- MAIN STUDY will focus on 30 days survival (primary end point) and other important clinical outcomes (secondary outcomes)
Objective pre study RUN-IN period:
In order to test the technical inclusion procedures, logistics, feasibility and data collection a pre-study RUN-IN period started in Stockholm during 2015.
Objective PILOT study:
The aim of the PILOT study is to assess safety and feasibility of the TANGO2 trial design, as well as intermediate clinical outcomes. The TANGO2 trial started recruitment of patients on January 1st 2017 and last patient was included on December 31st 2018. All patients from the PILOT study will be included in the MAIN STUDY in a seamless design.
Objective MAIN study:
The aim of the MAIN study is to evaluate whether survival to 30 days following instructions to perform CO-CPR is non-inferior compared to instructions to perform S-CPR bystanders in witnessed OHCA where the bystander has previous CPR training. Secondary and exploratory objectives include the evaluation of neurological favorable survival, return of spontaneous circulation, admission to hospital, long-term survival and other clinical outcome variables as well as evaluations of 30-day survival between CO-CPR and S-CPR in pre-specified subgroups. The MAIN study will include patients from the PILOT phase in a seamless design
Experiences from the pre study RUN-IN period and implications for the PILOT and MAIN studies:
The pre-study RUN-IN period started in Stockholm County in 2015 and analysis were performed during 2016. After continuous technological adjustments, the randomization module was integrated within the computer aided dispatch system and was found to functioned well in the end of 2016. However, during pre-study RUN-IN period, one major obstacle was identified. Due to unexpected technological matters and an unanticipated new organization of the dispatch centers in Sweden only about 15% of the cardiac arrest calls for patients suffering cardiac arrest in Stockholm were actually answered by dispatchers in Stockholm; all other calls were transferred to other dispatch centers throughout Sweden. This meant that the dispatchers had to consider the geographical site of the suspected cardiac arrest and remember if that area was part of the study area. This new organization and logistics, were the call could be made in one area and answered and handled at another site and county during the pre-study RUN-IN period, resulted in a far greatly slower inclusion rate than anticipated and made a correct follow-up of patients unmanageable and unreliable. This made it impossible to conduct a PILOT study in Stockholm only.
As a consequence, a decision was made by the steering committee:
- To move the start of the PILOT study forward, until completion of the national expansion of the study and not to start inclusion of patients into the PILOT study before January 1st 2017. The new length of the PILOT study was set to two years to assure sufficient inclusion of patients to assess safety in terms of survival to hospital admission.
- That the PILOT study seamlessly will move on into the MAIN study in an inferentially seamless manner after the PILOT phase inclusion ended on Dec 31 2018. This means that patients from the PILOT study will also be included in the MAIN survival study. The outcomes for the PILOT study were changed to not interfere with the primary endpoint of the main survival study (30-day survival).
Inclusion and Exclusion criteria remained unchanged throughout the TANGO2-project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO-CPR Bystander | Experimental | Procedure: CO-CPRInstructions by dispatcher to trained bystander to provide CPR with chest-compressions only |
| S-CPR Bystander | Active comparator | Procedure: S-CPRInstructions by dispatcher to trained bystander to provide CPR with chest-compressions and rescue breaths in a 30:2 ratio |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unconsciousness with no, abnormal or agonal breathing (suspected OHCA)
- The suspected OHCA is witnessed (seen or heard)
- Bystander has previous training in CPR
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO-CPRAlso: Compression only CPR, Continous Chest CompressionsCPR provided by bystander with chest-compressions only | Procedure or surgery | CO-CPR Bystander |
| S-CPRAlso: Standard CPRCPR with Chest Compressions and Rescue Breaths in a ratio of 30:2 | Procedure or surgery | S-CPR Bystander |
Primary outcome
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
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
3 secondary outcomes
Proportions of patients with ventricular fibrillation/ ventricular tachycardia (ITT and PP)
Time frame: within minutes from arrival of the EMS (day 1)
Proportion of patients who achieve return of spontaneous circulation (ROSC)
Time frame: day 1
Survival to hospital admission
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Derived from this study: PubMed 38445487Riva G, Boberg E, Ringh M, Jonsson M, Claesson A, Nord A, Rubertsson S, Blomberg H, Nordberg P, Forsberg S, Rosenqvist M, Svensson L, Andrell C, Herlitz J, Hollenberg J. Compression-Only or Standard Cardiopulmonary Resuscitation for Trained Laypersons in Out-of-Hospital Cardiac Arrest: A Nationwide Randomized Trial in Sweden. Circ Cardiovasc Qual Outcomes. 2024 Mar;17(3):e010027. doi: 10.1161/CIRCOUTCOMES.122.010027. Epub 2024 Mar 6.
- Individual participant dataSharing planned: No. Data will be published on group level only
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Hollenberg, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO-CPR and S-CPR in people with Cardiac Arrest and Out of Hospital Cardiac Arrest, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive measurement of feasibility (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02401633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.