Heart ArrestPhase 3NCT00219687
Dispatcher-Assisted Resuscitation Trial (DART)
A Phase 3 study testing dispatcher-assisted CPR with compressions & ventilations and dispatcher-assisted CPR instructions with compressions only in people with Heart Arrest, run by Public Health - Seattle and King County at 3 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether dispatcher-assisted CPR instructions with compressions and ventilations versus dispatcher-assisted CPR instructions with compressions only improves survival from out-of-hospital cardiac arrests. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Heart Arrest
- What is being tested?
- dispatcher-assisted CPR with compressions & ventilations and dispatcher-assisted CPR instructions with compressions only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,494 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2004to Aug 2012
- Phase
- Phase 3
- 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 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cardiac arrest events where CPR is not ongoing but a bystander is willing to attempt with assistance
Who cannot join
- Pregnancy
- Prisoners
- Cardiac arrest due to asphyxia, drowning, hanging, or electrocution
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Thurston County Dispatch
Olympia, Washington
Division of Emergency Medical Services, Public Health - Seattle and King County
Seattle, Washington, 98104
About this study
Official title: Randomized Trial of Dispatcher-Assisted CPR:Chest Compression Alone Versus Chest Compression Plus Ventilation
The purpose of this study is to determine whether dispatcher-assisted CPR instructions with compressions and ventilations versus dispatcher-assisted CPR instructions with compressions only improves survival from out-of-hospital cardiac arrests.
Read the detailed description
Out-of-hospital cardiac arrest, a condition characterized by a person suddenly collapsing due to heart stoppage, is a leading cause of death in the United States. In out-of-hospital cardiac arrest, survival is dependent upon what the American Heart Association has termed the chain of survival which includes quick activation of the 9-1-1 system, prompt cardiopulmonary resuscitation (CPR), early defibrillation, and qualified advanced life support care (paramedic care). CPR allows for some circulation and delivery of oxygen to vital organs when the heart is no longer beating on its own. However, in some instances, the citizen bystander has not been trained in CPR, presenting a circumstance where the cardiac arrest victim may not receive CPR until the arrival of emergency medical services (EMS) personnel (i.e., paramedics). The delay in CPR adversely affects outcome and dcreases the chance of survival. In response to this need, the EMS Division of Public Health - Seattle and King County developed and instituted telephone CPR instructions that could be provided "on-the-spot" during a cardiac arrest by the emergency medical (9-1-1) dispatcher. The instructions are designed to be given over the phone to persons who have not had previous CPR training so that they can initiate CPR prior to the arrival of EMS personnel and have been termed "dispatcher-assisted" CPR. The dispatcher instructions provided by the dispatch agencies of King County include the standard "full" CPR protocol of ventilations (breathing into the victim's mouth to inflate the lungs) and chest compressions(pumping on the patients chest to help circulate the blood). The ventilations oxygenate the blood while the chest compressions pump the oxygenated blood forward. This EMS program has led to a considerable increase in the proportion of cardiac arrest victims in King County that receive citizen bystander CPR prior to EMS arrival and has been associated with improved survival (appendix 1).
Comparison: Dispatcher-assisted CPR instructions with compressions and ventillations compared to dispatcher-assisted CPR instructions with compressions only.
- Conditions
- Heart Arrest
- Being tested
- dispatcher-assisted CPR with compressions & ventilations, dispatcher-assisted CPR instructions with compressions only
- Keywords
- Heart arrest, Cardiopulmonary resuscitation, Dispatcher
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dispatcher-assisted CPR with compressions & ventilationsOther
Delivery of telephone CPR instructions to lay callers with chest compressions and ventilations when the patient is identified to be in cardiac arrest
dispatcher-assisted CPR instructions with compressions onlyOther
Delivery of telephone CPR instructions to lay callers with hands-only chest compressions when the patient is identified to be in cardiac arrest
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | When a 911 call is determined to be a cardiac arrest, the caller reporting the event who needs or desires instructions to perform CPR while waiting for EMS to arrive will receive dispatcher-assisted CPR instructions with chest compressions only Receives: Other: dispatcher-assisted CPR instructions with compressions only |
| 2 | Active comparator | When a 911 call is determined to be a cardiac arrest, the caller reporting the event who needs or desires instructions to perform CPR while waiting for EMS to arrive will receive dispatcher-assisted CPR instructions with chest compressions and breaths Receives: Other: dispatcher-assisted CPR with compressions & ventilations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to hospital discharge
assessed at hospital discharge
Measured: varied
Secondary outcomes (1)
Neurological status at hospital discharge
assessed at hospital discharge
Measured: varied
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionAug 2012
- Study completionAug 2012
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 Heart ArrestStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health - Seattle and King County
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Susan Damon, Public Health - Seattle and King County
- Investigators
- Thomas D Rea, MD, MPH, Principal investigator, Division of Emergency Medical Services, Public Health - Seattle and King CountyMickey S Eisenberg, MD, PhD, Principal investigator, Division of Emergency Medical Services, Public Health - Seattle and King County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219687
- Sponsor's protocol ID
- RARC-0001-01
- Status last verified
- Oct 2014
- First submitted
- 13 Sep 2005
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rea TD, Fahrenbruch C, Culley L, Donohoe RT, Hambly C, Innes J, Bloomingdale M, Subido C, Romines S, Eisenberg MS. CPR with chest compression alone or with rescue breathing. N Engl J Med. 2010 Jul 29;363(5):423-33. doi: 10.1056/NEJMoa0908993.
PubMed 20818863
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Dispatcher-Assisted CPR:Chest Compression Alone Versus Chest Compression Plus Ventilation
- ClinicalTrials.gov ID
- NCT00219687
- Acronym / sponsor ID
- RARC-0001-01
- Conditions
- Heart Arrest
- Keywords
- Heart arrest, Cardiopulmonary resuscitation, Dispatcher
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,494 participants (actual)
- Lead sponsor
- Public Health - Seattle and King CountyOther government
- Study start
- Jun 2004
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 22 Sep 2005 (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.
The purpose of this study is to determine whether dispatcher-assisted CPR instructions with compressions and ventilations versus dispatcher-assisted CPR instructions with compressions only improves survival from out-of-hospital cardiac arrests.
Detailed description
Out-of-hospital cardiac arrest, a condition characterized by a person suddenly collapsing due to heart stoppage, is a leading cause of death in the United States. In out-of-hospital cardiac arrest, survival is dependent upon what the American Heart Association has termed the chain of survival which includes quick activation of the 9-1-1 system, prompt cardiopulmonary resuscitation (CPR), early defibrillation, and qualified advanced life support care (paramedic care). CPR allows for some circulation and delivery of oxygen to vital organs when the heart is no longer beating on its own. However, in some instances, the citizen bystander has not been trained in CPR, presenting a circumstance where the cardiac arrest victim may not receive CPR until the arrival of emergency medical services (EMS) personnel (i.e., paramedics). The delay in CPR adversely affects outcome and dcreases the chance of survival. In response to this need, the EMS Division of Public Health - Seattle and King County developed and instituted telephone CPR instructions that could be provided "on-the-spot" during a cardiac arrest by the emergency medical (9-1-1) dispatcher. The instructions are designed to be given over the phone to persons who have not had previous CPR training so that they can initiate CPR prior to the arrival of EMS personnel and have been termed "dispatcher-assisted" CPR. The dispatcher instructions provided by the dispatch agencies of King County include the standard "full" CPR protocol of ventilations (breathing into the victim's mouth to inflate the lungs) and chest compressions(pumping on the patients chest to help circulate the blood). The ventilations oxygenate the blood while the chest compressions pump the oxygenated blood forward. This EMS program has led to a considerable increase in the proportion of cardiac arrest victims in King County that receive citizen bystander CPR prior to EMS arrival and has been associated with improved survival (appendix 1).
Comparison: Dispatcher-assisted CPR instructions with compressions and ventillations compared to dispatcher-assisted CPR instructions with compressions only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: dispatcher-assisted CPR instructions with compressions onlyWhen a 911 call is determined to be a cardiac arrest, the caller reporting the event who needs or desires instructions to perform CPR while waiting for EMS to arrive will receive dispatcher-assisted CPR instructions with chest compressions only |
| 2 | Active comparator | Other: dispatcher-assisted CPR with compressions & ventilationsWhen a 911 call is determined to be a cardiac arrest, the caller reporting the event who needs or desires instructions to perform CPR while waiting for EMS to arrive will receive dispatcher-assisted CPR instructions with chest compressions and breaths |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cardiac arrest events where CPR is not ongoing but a bystander is willing to attempt with assistance
Key exclusion criteria (3 listed)
- Pregnancy
- Prisoners
- Cardiac arrest due to asphyxia, drowning, hanging, or electrocution
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 |
|---|---|---|
| dispatcher-assisted CPR with compressions & ventilationsDelivery of telephone CPR instructions to lay callers with chest compressions and ventilations when the patient is identified to be in cardiac arrest | Other | 2 |
| dispatcher-assisted CPR instructions with compressions onlyDelivery of telephone CPR instructions to lay callers with hands-only chest compressions when the patient is identified to be in cardiac arrest | Other | 1 |
Primary outcome
Survival to hospital discharge
Time frame: varied
assessed at hospital discharge
1 secondary outcome
Neurological status at hospital discharge
Time frame: varied
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 29 Oct 2014.
- Derived from this study: PubMed 20818863Rea TD, Fahrenbruch C, Culley L, Donohoe RT, Hambly C, Innes J, Bloomingdale M, Subido C, Romines S, Eisenberg MS. CPR with chest compression alone or with rescue breathing. N Engl J Med. 2010 Jul 29;363(5):423-33. doi: 10.1056/NEJMoa0908993.
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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.
Thomas D Rea, MD, MPH principal investigator
Division of Emergency Medical Services, Public Health - Seattle and King County
Mickey S Eisenberg, MD, PhD principal investigator
Division of Emergency Medical Services, Public Health - Seattle and King County
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dispatcher-assisted CPR with compressions & ventilations and dispatcher-assisted CPR instructions with compressions only in people with Heart Arrest, run by Public Health - Seattle and King County at 3 sites in 2 countries.
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 3 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 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, United Kingdom. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Survival to hospital discharge (time frame: varied). 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 NCT00219687, 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 29 Oct 2014.