Out-of-Hospital Cardiac Arrest2% ProjectNCT02540629
Implementation of Gold Standard EMS CPR Programs for 2% Improvement in Survival Rates of Out-of-Hospital Cardiac Arrest in a Metropolitan City
A study testing Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device in people with Out-of-Hospital Cardiac Arrest, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to improve the survival rate of out-of-hospital cardiac arrest patients by 2% through a bundle of three intervention measures including: 1) dispatcher-assisted CPR, 2) multi-tiered response team CPR, and 3) feedback CPR. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest
- What is being tested?
- Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,670 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- EMS-assessed OHCA
- Cardiac etiology
- Above 15 years of age
Who cannot join
- Patients who do not receive EMS resuscitation
- Patients with signs of evident death (decapitation, evident livor mortis or rigor mortis)
- Do-Not-Resuscitate cases
- Pregnant patients
- Patients whom the mechanical devices cannot be applied to
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to improve the survival rate of out-of-hospital cardiac arrest patients by 2% through a bundle of three intervention measures including: 1) dispatcher-assisted CPR, 2) multi-tiered response team CPR, and 3) feedback CPR.
Read the detailed description
The project aims to implement gold standard emergency medical services (EMS) cardiopulmonary resuscitation (CPR) programs, which will result in increased bystander CPR, reduced EMS response time, and high quality CPR during prehospital resuscitation through a bundled approach including 1) dispatcher-assisted CPR (DA-CPR), 2) multi-tiered response team CPR, and 3) feedback CPR.
The DA-CPR program aims to contribute to improved bystander CPR rate and reduced EMS response time interval through rigorous monitoring of cardiac arrest detection at primary call receiving stage as well as increased number of dispatcher-assisted CPR instruction initiation in the target time of 90 seconds. The Team CPR protocol will render synergetic efforts among participating EMS personnel from both basic life support (BLS) and advanced life support (ALS) units within the new tiered dispatch system and subsequently deliver uninterrupted CPR to out-of-hospital cardiac arrest (OHCA) patients before hospital arrival. The feedback CPR monitoring and quality assurance program will contribute to high quality CPR delivered to the patients on the scene as well as during transport.
- Conditions
- Out-of-Hospital Cardiac Arrest
- Being tested
- Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device
- Keywords
- Cardiopulmonary resuscitation, Emergency Medicine
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring deviceProcedure or surgery
Gold standard EMS CPR refers to our bundled approach to providing high quality EMS CPR through one or more intervention(s) as applicable including 1) dispatcher-assisted CPR, 2) multi-tiered team CPR, and 3) feedback CPR.
| Study group | Role | What they receive |
|---|---|---|
| Before intervention | No intervention | The before intervention group will include patients from January, 2013 through December, 2014, as to refer to the historic control population who did not receive any of study interventions. |
| After intervention | Experimental | The main study phase was planned to begin in January, 2016 through December, 2017, for a total of two years. Patients during the main study phase will have received one or more study interventions as applicable. However, because we could not continue our project in 2017, we changed after period. We included implementation period (2015) in after period. Therefore, final after period begins in January 2015 to December 2016. Receives: Procedure: Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Survival to Hospital Discharge
Number of EMS-assessed out-of-hospital cardiac arrest patients who survive to hospital discharge will be recorded.
Measured: At hospital discharge, up to 28 weeks from hospital admission
Secondary outcomes (1)
Number of Participants With Good Neurological Recovery at Discharge
Number of EMS-assessed out-of-hospital cardiac arrest patients who survive to hospital discharge and has cerebral performance category 1 or 2 will be recorded.
Measured: At hospital discharge, up to 28 weeks from hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study start1 Jan 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: Human resource change in Research investigators and Seoul Fire Department
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Out-of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12,670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Do Shin, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540629
- Sponsor's protocol ID
- SNUH-EM-2015-3
- Acronym
- 2% Project
- Status last verified
- Mar 2020
- First submitted
- 6 Aug 2015
- Last updated
- 30 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Gold Standard EMS CPR Programs for 2% Improvement in Survival Rates of Out-of-Hospital Cardiac Arrest in a Metropolitan City
- ClinicalTrials.gov ID
- NCT02540629
- Acronym / sponsor ID
- 2% Project / SNUH-EM-2015-3
- Conditions
- Out-of-Hospital Cardiac Arrest
- Keywords
- Cardiopulmonary resuscitation, Emergency Medicine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Human resource change in Research investigators and Seoul Fire Department
- Enrolment
- 12,670 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Posted 30 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to improve the survival rate of out-of-hospital cardiac arrest patients by 2% through a bundle of three intervention measures including: 1) dispatcher-assisted CPR, 2) multi-tiered response team CPR, and 3) feedback CPR.
Detailed description
The project aims to implement gold standard emergency medical services (EMS) cardiopulmonary resuscitation (CPR) programs, which will result in increased bystander CPR, reduced EMS response time, and high quality CPR during prehospital resuscitation through a bundled approach including 1) dispatcher-assisted CPR (DA-CPR), 2) multi-tiered response team CPR, and 3) feedback CPR.
The DA-CPR program aims to contribute to improved bystander CPR rate and reduced EMS response time interval through rigorous monitoring of cardiac arrest detection at primary call receiving stage as well as increased number of dispatcher-assisted CPR instruction initiation in the target time of 90 seconds. The Team CPR protocol will render synergetic efforts among participating EMS personnel from both basic life support (BLS) and advanced life support (ALS) units within the new tiered dispatch system and subsequently deliver uninterrupted CPR to out-of-hospital cardiac arrest (OHCA) patients before hospital arrival. The feedback CPR monitoring and quality assurance program will contribute to high quality CPR delivered to the patients on the scene as well as during transport.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before intervention | No intervention | –The before intervention group will include patients from January, 2013 through December, 2014, as to refer to the historic control population who did not receive any of study interventions. |
| After intervention | Experimental | Procedure: Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring deviceThe main study phase was planned to begin in January, 2016 through December, 2017, for a total of two years. Patients during the main study phase will have received one or more study interventions as applicable. However, because we could not continue our project in 2017, we changed after period. We included implementation period (2015) in after period. Therefore, final after period begins in January 2015 to December 2016. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- EMS-assessed OHCA
- Cardiac etiology
- Above 15 years of age
Key exclusion criteria (5 listed)
- Patients who do not receive EMS resuscitation
- Patients with signs of evident death (decapitation, evident livor mortis or rigor mortis)
- Do-Not-Resuscitate cases
- Pregnant patients
- Patients whom the mechanical devices cannot be applied to
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 |
|---|---|---|
| Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring deviceGold standard EMS CPR refers to our bundled approach to providing high quality EMS CPR through one or more intervention(s) as applicable including 1) dispatcher-assisted CPR, 2) multi-tiered team CPR, and 3) feedback CPR. | Procedure or surgery | After intervention |
Primary outcome
Number of Participants With Survival to Hospital Discharge
Time frame: At hospital discharge, up to 28 weeks from hospital admission
Number of EMS-assessed out-of-hospital cardiac arrest patients who survive to hospital discharge will be recorded.
1 secondary outcome
Number of Participants With Good Neurological Recovery at Discharge
Time frame: At hospital discharge, up to 28 weeks from hospital admission
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Out-of-Hospital Cardiac Arrest
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
Not yet recruiting
The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device in people with Out-of-Hospital Cardiac Arrest, run by Seoul National University Hospital at 1 site in South Korea.
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 5 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: stopped early, as of the sponsor's last update on 30 Mar 2020. 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 30 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Survival to Hospital Discharge (time frame: At hospital discharge, up to 28 weeks from hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2020.