Compression Only CPR Versus Standard CPR in Out-Of-Hospital Cardiac Arrest - A Randomized Survival Study (TANGO2)
Primary Purpose
Out-Of-Hospital Cardiac Arrest, Cardiac Arrest, Cardiopulmonary Resuscitation
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Chest Compression Only CPR (CO-CPR) performed by trained bystanders after instructions from dispatchers
Standard CPR (S-CPR) performed by trained bystanders after instructions from dispatchers
Sponsored by
About this trial
This is an interventional treatment trial for Out-Of-Hospital Cardiac Arrest focused on measuring Cardiopulmonary Resuscitation, Chest compressions only CPR, Dispatcher assisted CPR, Cardiac Arrest
Eligibility 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)
Sites / Locations
- SOS Alarm ABRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Chest Compression Only CPR (CO-CPR)
Standard CPR (S-CPR)
Arm Description
Instructions from a dispatcher at the dispatch center to trained bystanders to perform CO-CPR with chest compressions only.
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.
Outcomes
Primary Outcome Measures
30-day survival
Survival to 30 days after cardiac arrest
Secondary Outcome Measures
Survival to hospital admission
Survival to admission to hospital
One year survival
Survival to one year after cardiac arrest
Survival with good neurologic outcome at discharge
Survival to hospital discharge with cerebral performance category (CPC) 1-2
Survival with complete neurologically outcome
Survival to hospital discharge with cerebral performance category (CPC) 1
Full Information
NCT ID
NCT03981107
First Posted
June 5, 2019
Last Updated
April 1, 2023
Sponsor
Karolinska Institutet
Collaborators
Swedish Heart Lung Foundation, The Swedish Research Council, SOS Alarm
1. Study Identification
Unique Protocol Identification Number
NCT03981107
Brief Title
Compression Only CPR Versus Standard CPR in Out-Of-Hospital Cardiac Arrest - A Randomized Survival Study
Acronym
TANGO2
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Swedish Heart Lung Foundation, The Swedish Research Council, SOS Alarm
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
This is an interventional, prospective, randomized, 1:1 open label, multicenter trial comparing two different methods of bystander CPR in witnessed cases of OHCA. Since CO-CPR is a simplified form of CPR that could lead to a higher incidence of bystander-CPR by itself a non-inferiority design for the primary outcome has been chosen. Superiority testing will also be performed for the purpose of demonstrating a possible increase in survival with CO-CPR.
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. If included, it will be randomly assigned to either CO-CPR (intervention) or S-CPR (control).
The intervention consists of instructions from a dispatcher at the dispatch center to bystanders to perform either CO-CPR (intervention) or S-CPR (control).
Instructions to bystanders on how to perform CO-CPR includes continuous chest compressions without interruptions or rescue breaths.
Instructions to bystanders 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 recruiting)
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 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:
A) 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.
B) 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 (see below). Inclusion and Exclusion criteria remained unchanged throughout the TANGO2-project.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-Of-Hospital Cardiac Arrest, Cardiac Arrest, Cardiopulmonary Resuscitation
Keywords
Cardiopulmonary Resuscitation, Chest compressions only CPR, Dispatcher assisted CPR, Cardiac Arrest
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, 1:1, open label, multicenter trial
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
3260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chest Compression Only CPR (CO-CPR)
Arm Type
Experimental
Arm Description
Instructions from a dispatcher at the dispatch center to trained bystanders to perform CO-CPR with chest compressions only.
Arm Title
Standard CPR (S-CPR)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Chest Compression Only CPR (CO-CPR) performed by trained bystanders after instructions from dispatchers
Other Intervention Name(s)
Chest compression only CPR, Compression only CPR, Hands-only CPR
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard CPR (S-CPR) performed by trained bystanders after instructions from dispatchers
Other Intervention Name(s)
Standard CPR
Intervention Description
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.
Primary Outcome Measure Information:
Title
30-day survival
Description
Survival to 30 days after cardiac arrest
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Survival to hospital admission
Description
Survival to admission to hospital
Time Frame
1 day
Title
One year survival
Description
Survival to one year after cardiac arrest
Time Frame
1 year
Title
Survival with good neurologic outcome at discharge
Description
Survival to hospital discharge with cerebral performance category (CPC) 1-2
Time Frame
30 days
Title
Survival with complete neurologically outcome
Description
Survival to hospital discharge with cerebral performance category (CPC) 1
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Proportion of participants found with VT/VF at first rhythm analysis
Description
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)
Time Frame
1 day
Title
Proportion of participants with return of spontaneous Circulation (ROSC)
Description
Proportion of participants with return of spontaneous Circulation
Time Frame
1 day
Title
Analysis of primary endpoint (30-day survival) in pre-defined subgroup
Description
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)
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriel Riva, MD
Phone
0046705452086
Email
gabriel.riva@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Hollenberg, MD, PhD
Phone
004686163816
Email
Jacob.hollenberg@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Hollenberg, MD, PhD
Organizational Affiliation
Karolinska Institutet, Department of Medicine Solna
Official's Role
Principal Investigator
Facility Information:
Facility Name
SOS Alarm AB
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be published on group level only
Learn more about this trial
Compression Only CPR Versus Standard CPR in Out-Of-Hospital Cardiac Arrest - A Randomized Survival Study
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