Out of Hospital Cardiac ArrestHEROSNCT02142387
Effects of a New Dispatcher-Assisted Basic Life Support Training Program
A study testing BLS CPR program with dispatcher assisted CPR simulation in people with Out of Hospital Cardiac Arrest, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Despite aggressive cardiopulmonary resuscitation (CPR) training, the outcome of cardiac arrest is not good. The problem is method of education. So, the investigators want to add the dispatcher-assisted CPR simulation into conventional CPR training. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Out of Hospital Cardiac Arrest
- What is being tested?
- BLS CPR program with dispatcher assisted CPR simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,822 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All out-of-hospital cardiac arrest (OHCA) patients with presumed cardiac etiology who are 19 years of age or older and assessed and treated by EMS providers after dispatched by the EMS dispatch center will be included.
Who cannot join
- We will exclude patients with non-cardiac etiology, prolonged cardiac arrest with a suspected duration more than 30 minutes, cases such as livor mortis or rigor mortis, and decapitated or decomposed body, and patients who have "Do-Not-Resuscitate" card documented by doctor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effects of a New Dispatcher-Assisted Basic Life Support Training Program in a Metropolitan City: A Before-and-After Intervention Study
Despite aggressive cardiopulmonary resuscitation (CPR) training, the outcome of cardiac arrest is not good. The problem is method of education. So, the investigators want to add the dispatcher-assisted CPR simulation into conventional CPR training. In this study, the study is aimed to investigate the effect of newer CPR training program.
Read the detailed description
The training program focuses on working in team with dispatcher, performing all steps from recognizing cardiac arrest to performing CPR, together with the dispatcher. The one hours training session is split into four parts:
- Video self-instruction manikin practice (30 min), including a brief introduction to automated external defibrillator (AED).
- Practice in pairs (15 min). Practicing the dispatcher and rescuer role in a simulation to enhance learning.
- Debriefing. Questions, answers and reflection (15 min).
- Homework. Leaflet with tasks like learn how to activate the speaker function on your own phone.
The main difference between dispatcher-assisted basic life support (DA-BLS) and traditional BLS training is that DA-BLS provides the scenes and interactive experiences on calling emergency medical service (EMS) and receiving CPR instruction via telephone speaker function, following up the skill training by scenario simulation training.
- Conditions
- Out of Hospital Cardiac Arrest
- Being tested
- BLS CPR program with dispatcher assisted CPR simulation
- Keywords
- cardiac arrest, dispatcher-assisted bystander cardiopulmonary resuscitation, survival
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLS CPR program with dispatcher assisted CPR simulationOther
the training program more focuses on cooperation with a dispatcher, from recognition to perform DA-CPR and hands-on practice.
| Study group | Role | What they receive |
|---|---|---|
| New DA-BLS training program | Active comparator | A one-hour training course that includes a 30-minute video-based self-instruction (VSI) training session, a short role-play, and a debriefing. The video consists of a bystander CPR simulation with dispatcher instructions using the trainee's own phone and practice session following demonstration by a simulated layperson. After watching the video clip, all trainees are divided into two groups and conduct a role-play as dispatchers and laypersons for 15 minutes. Finally, there is a 15-minute debriefing session with several assignments. The HEROS program focuses on cooperation with a dispatcher, from recognition of cardiac arrest to performing DA-CPR, with hands-on practice so that laypersons can provide bystander CPR immediately in a real situation. Moreover, the HEROS program emphasizes practice for providing the correct address of the scene and switching to speakerphone mode, especially for the elderly. Receives: Other: BLS CPR program with dispatcher assisted CPR simulation |
| Current Basic Life Support (BLS) training program | No intervention | A one-hour training program that was developed by the Korea Center for Disease Control and Prevention (CDC) and it was based on the American Heart Association (AHA) guideline (http://www.cdc.go.kr/board.es?mid=a20503050000\&bid=0021\&tag=\&act=view\&list_no=127655). The program consists of a 30-minute VSI, and a 30-minute practice debriefing session. It focuses on detailed techniques for performing high-quality chest compressions including the correct hands and body position of the bystanders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Surviving to Hospital Discharge
The study end points are survival to hospital discharge. Survival to discharge will be measured as proportions of patients who were discharged from a hospital with their spontaneous circulation recovered. This information will be collected from medical record review.
Measured: from date of discharge, assessed up to 3 months
Secondary outcomes (2)
Number of Participants With Return of Spontaneous Circulation (ROSC)
The return of spontaneous circulation will be measured as proportion of the patients who were recovered their circulation at emergency department. This information will be collected from the medical review.
Measured: from date of cardiac arrest occurred, assessed up to 1 week
Number of Participants With Good Neurological Recovery
The Cerebral Performance Categories (CPC) score will be used to measure neurological recovery status: CPC 1 (good cerebral performance), CPC 2 (moderate cerebral disability), CPC 3 (severe cerebral disability), CPC 4 (coma or vegetative state), CPC 5 (brain death).
We defined the good neurological recovery as CPC 1 or CPC 2. This information will be collected from medical record review.
Measured: from date of discharge, assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2017
- Study completionDec 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 18,822 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
- Investigators
- Sang Do Shin, MD, MPH, PHD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142387
- Sponsor's protocol ID
- SNUH-heros-01
- Acronym
- HEROS
- Status last verified
- Apr 2020
- First submitted
- 13 May 2014
- Last updated
- 1 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Park GJ, Song KJ, Shin SD, Hong KJ, Kim TH, Park YM, Kong J. Clinical effects of a new dispatcher-assisted basic life support training program in a metropolitan city. Medicine (Baltimore). 2022 Jul 15;101(28):e29298. doi: 10.1097/MD.0000000000029298.
PubMed 35839001
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of a New Dispatcher-Assisted Basic Life Support Training Program in a Metropolitan City: A Before-and-After Intervention Study
- ClinicalTrials.gov ID
- NCT02142387
- Acronym / sponsor ID
- HEROS / SNUH-heros-01
- Conditions
- Out of Hospital Cardiac Arrest
- Keywords
- cardiac arrest, dispatcher-assisted bystander cardiopulmonary resuscitation, survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18,822 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Posted 1 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite aggressive cardiopulmonary resuscitation (CPR) training, the outcome of cardiac arrest is not good. The problem is method of education. So, the investigators want to add the dispatcher-assisted CPR simulation into conventional CPR training. In this study, the study is aimed to investigate the effect of newer CPR training program.
Detailed description
The training program focuses on working in team with dispatcher, performing all steps from recognizing cardiac arrest to performing CPR, together with the dispatcher. The one hours training session is split into four parts:
- Video self-instruction manikin practice (30 min), including a brief introduction to automated external defibrillator (AED).
- Practice in pairs (15 min). Practicing the dispatcher and rescuer role in a simulation to enhance learning.
- Debriefing. Questions, answers and reflection (15 min).
- Homework. Leaflet with tasks like learn how to activate the speaker function on your own phone.
The main difference between dispatcher-assisted basic life support (DA-BLS) and traditional BLS training is that DA-BLS provides the scenes and interactive experiences on calling emergency medical service (EMS) and receiving CPR instruction via telephone speaker function, following up the skill training by scenario simulation training.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New DA-BLS training program | Active comparator | Other: BLS CPR program with dispatcher assisted CPR simulationA one-hour training course that includes a 30-minute video-based self-instruction (VSI) training session, a short role-play, and a debriefing. The video consists of a bystander CPR simulation with dispatcher instructions using the trainee's own phone and practice session following demonstration by a simulated layperson. After watching the video clip, all trainees are divided into two groups and conduct a role-play as dispatchers and laypersons for 15 minutes. Finally, there is a 15-minute debriefing session with several assignments. The HEROS program focuses on cooperation with a dispatcher, from recognition of cardiac arrest to performing DA-CPR, with hands-on practice so that laypersons can provide bystander CPR immediately in a real situation. Moreover, the HEROS program emphasizes practice for providing the correct address of the scene and switching to speakerphone mode, especially for the elderly. |
| Current Basic Life Support (BLS) training program | No intervention | –A one-hour training program that was developed by the Korea Center for Disease Control and Prevention (CDC) and it was based on the American Heart Association (AHA) guideline (http://www.cdc.go.kr/board.es?mid=a20503050000\&bid=0021\&tag=\&act=view\&list_no=127655). The program consists of a 30-minute VSI, and a 30-minute practice debriefing session. It focuses on detailed techniques for performing high-quality chest compressions including the correct hands and body position of the bystanders. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All out-of-hospital cardiac arrest (OHCA) patients with presumed cardiac etiology who are 19 years of age or older and assessed and treated by EMS providers after dispatched by the EMS dispatch center will be included.
Key exclusion criteria (1 listed)
- We will exclude patients with non-cardiac etiology, prolonged cardiac arrest with a suspected duration more than 30 minutes, cases such as livor mortis or rigor mortis, and decapitated or decomposed body, and patients who have "Do-Not-Resuscitate" card documented by doctor.
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 |
|---|---|---|
| BLS CPR program with dispatcher assisted CPR simulationthe training program more focuses on cooperation with a dispatcher, from recognition to perform DA-CPR and hands-on practice. | Other | New DA-BLS training program |
Primary outcome
Number of Participants Surviving to Hospital Discharge
Time frame: from date of discharge, assessed up to 3 months
The study end points are survival to hospital discharge. Survival to discharge will be measured as proportions of patients who were discharged from a hospital with their spontaneous circulation recovered. This information will be collected from medical record review.
2 secondary outcomes
Number of Participants With Return of Spontaneous Circulation (ROSC)
Time frame: from date of cardiac arrest occurred, assessed up to 1 week
Number of Participants With Good Neurological Recovery
Time frame: from date of discharge, assessed up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35839001Park GJ, Song KJ, Shin SD, Hong KJ, Kim TH, Park YM, Kong J. Clinical effects of a new dispatcher-assisted basic life support training program in a metropolitan city. Medicine (Baltimore). 2022 Jul 15;101(28):e29298. doi: 10.1097/MD.0000000000029298.
- Individual participant dataSharing planned: No
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.
Sang Do Shin, MD, MPH, PHD study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BLS CPR program with dispatcher assisted CPR simulation 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 1 inclusion and 1 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 1 May 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 1 May 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 Surviving to Hospital Discharge (time frame: from date of discharge, assessed up to 3 months). 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 NCT02142387, 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 1 May 2020.