Out of Hospital Cardiac ArrestNCT02010151
Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation
A study testing NAD-CPR in people with Out of Hospital Cardiac Arrest, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The hypothesis of this study is Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation (NAD-CPR) would improve survival of out-of-hospital cardiac arrest (OHCA). 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?
- NAD-CPR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,194 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Dec 2017
- 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
- all OHCA with presumed cardiac etiology more than 15 years old
- assessed by emergency medical service (EMS) providers dispatched by dispatch center
- dispatcher detected OHCA patients
Who cannot join
- OHCA with non-cardiac etiology
- prolonged cardiac arrest with a suspected duration more than 30 minutes
- cases with rigor mortis or rivor mortis, decapitated or decomposed body
- Non detected cases by dispatcher
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Population Based Intervention Trial of Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation
The hypothesis of this study is Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation (NAD-CPR) would improve survival of out-of-hospital cardiac arrest (OHCA).
Read the detailed description
Out-of-hospital cardiac arrest (OHCA) is a major health problem, occurring in about 1 in 1,500 adults in the developed countries each year. Although layperson CPR and defibrillation are crucial components of chain of survival, layperson CPR rate and it's quality is low and public-access defibrillation (PAD) program is not cost-effective.If trained bystanders can know the information of occurrence of OHCA and nearest place for automated external defibrillator (AED) at the same time by dispatch center, these neighborhoods could run and give high quality CPR and early defibrillation. If this protocol ,Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation(NAD-CPR), is introduced to community, it may improve survival of OHCA.
- Conditions
- Out of Hospital Cardiac Arrest
- Being tested
- NAD-CPR
- Keywords
- Out of Hospital Cardiac Arrest, Cardiopulmonary Resuscitation, dispatch, 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.
NAD-CPROther
When Dispatcher detects OHCA, short message service (SMS)about the OHCA event and information about the location of nearest AED is sent to trained laypersons within geographically accessible area.
| Study group | Role | What they receive |
|---|---|---|
| NAD-CPR | Experimental | When dispatcher detects a patient with OHCA, the dispatcher activates trained neighborhoods by informing events nearby using short message service via cellular phone. The neighborhood within geographically accessible area who could perform effective CPR and defibrillation would be alerted with event of OHCA and the nearest AED. Receives: Other: NAD-CPR |
| Conventional dispatcher assisted CPR | No intervention | When dispatcher detects OHCA, they instruct the caller with CPR instructions. This is conventional dispatcher assisted CPR performed in Seoul. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Surviving at Hospital Discharge
we compared the survival to discharge rate between before intervention period and intervention period.
Survival to discharge checked at the discharge point of hospital.
Measured: discharge time from first admission from emergency department within 2 month
Secondary outcomes (2)
Number of Participants With Pre-Hospital Return of Spontaneous Circulation (ROSC)
we compared the Pre-hospital return of spontaneous circulation (ROSC) rate between before intervention period and intervention period.
Measured: hospital arriving time from ambulance within 2 hours
Number of Participants With Good Neurological Recovery
Cerebral performance category 1 or 2 is defined as good neurological recovery. we compared the good neurological recovery rate between before intervention period and intervention period.
Measured: discharge time from first admission from emergency department within 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startMar 2015
- Primary completionDec 2017
- Study completionDec 2017
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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Center for Disease Control and Prevention, Seoul Metropolitan Government Health and Welfare Office, Seoul Metropolitan Fire and Disaster Headquater, Korea Association for Safety Community
- Responsible party
- Principal investigator, Sang Do Shin, Seoul National University Hospital
- Investigators
- Sang Do Shin, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010151
- Sponsor's protocol ID
- SNUEMS201309
- Status last verified
- Mar 2020
- First submitted
- 9 Dec 2013
- Last updated
- 30 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lee SY, Shin SD, Lee YJ, Song KJ, Hong KJ, Ro YS, Lee EJ, Kong SY. Text message alert system and resuscitation outcomes after out-of-hospital cardiac arrest: A before-and-after population-based study. Resuscitation. 2019 May;138:198-207. doi: 10.1016/j.resuscitation.2019.01.045. Epub 2019 Mar 19.
PubMed 30902689
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
- Population Based Intervention Trial of Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT02010151
- Acronym / sponsor ID
- SNUEMS201309
- Conditions
- Out of Hospital Cardiac Arrest
- Keywords
- Out of Hospital Cardiac Arrest, Cardiopulmonary Resuscitation, dispatch, emergency medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,194 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Korean Center for Disease Control and Prevention, Seoul Metropolitan Government Health and Welfare Office, Seoul Metropolitan Fire and Disaster Headquater, Korea Association for Safety Community
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Dec 2013 (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.
The hypothesis of this study is Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation (NAD-CPR) would improve survival of out-of-hospital cardiac arrest (OHCA).
Detailed description
Out-of-hospital cardiac arrest (OHCA) is a major health problem, occurring in about 1 in 1,500 adults in the developed countries each year. Although layperson CPR and defibrillation are crucial components of chain of survival, layperson CPR rate and it's quality is low and public-access defibrillation (PAD) program is not cost-effective.If trained bystanders can know the information of occurrence of OHCA and nearest place for automated external defibrillator (AED) at the same time by dispatch center, these neighborhoods could run and give high quality CPR and early defibrillation. If this protocol ,Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation(NAD-CPR), is introduced to community, it may improve survival of OHCA.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAD-CPR | Experimental | Other: NAD-CPRWhen dispatcher detects a patient with OHCA, the dispatcher activates trained neighborhoods by informing events nearby using short message service via cellular phone. The neighborhood within geographically accessible area who could perform effective CPR and defibrillation would be alerted with event of OHCA and the nearest AED. |
| Conventional dispatcher assisted CPR | No intervention | –When dispatcher detects OHCA, they instruct the caller with CPR instructions. This is conventional dispatcher assisted CPR performed in Seoul. |
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)
- all OHCA with presumed cardiac etiology more than 15 years old
- assessed by emergency medical service (EMS) providers dispatched by dispatch center
- dispatcher detected OHCA patients
Key exclusion criteria (4 listed)
- OHCA with non-cardiac etiology
- prolonged cardiac arrest with a suspected duration more than 30 minutes
- cases with rigor mortis or rivor mortis, decapitated or decomposed body
- Non detected cases by dispatcher
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 |
|---|---|---|
| NAD-CPRWhen Dispatcher detects OHCA, short message service (SMS)about the OHCA event and information about the location of nearest AED is sent to trained laypersons within geographically accessible area. | Other | NAD-CPR |
Primary outcome
Number of Participants Surviving at Hospital Discharge
Time frame: discharge time from first admission from emergency department within 2 month
we compared the survival to discharge rate between before intervention period and intervention period. Survival to discharge checked at the discharge point of hospital.
2 secondary outcomes
Number of Participants With Pre-Hospital Return of Spontaneous Circulation (ROSC)
Time frame: hospital arriving time from ambulance within 2 hours
Number of Participants With Good Neurological Recovery
Time frame: discharge time from first admission from emergency department within 2 month
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.
- Derived from this study: PubMed 30902689Lee SY, Shin SD, Lee YJ, Song KJ, Hong KJ, Ro YS, Lee EJ, Kong SY. Text message alert system and resuscitation outcomes after out-of-hospital cardiac arrest: A before-and-after population-based study. Resuscitation. 2019 May;138:198-207. doi: 10.1016/j.resuscitation.2019.01.045. Epub 2019 Mar 19.
Related trials for Out of Hospital Cardiac Arrest
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
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Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
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
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, PhD principal investigator
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 NAD-CPR 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 4 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 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 Surviving at Hospital Discharge (time frame: discharge time from first admission from emergency department within 2 month). 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 NCT02010151, 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 30 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.