Heart ArrestNCT03894059
An Educational Program to Improve Cardiac Arrest Diagnostic Accuracy of Ambulance Telecommunicators
An observational study of Heart Arrest and Heart Arrest, Out-Of-Hospital, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Cardiac arrest is the number one cause of death in Canada. It is often the first symptom of cardiac disease for the victims. Eighty-five percent of victims collapse in their own home. Fifty percent collapse in the presence of a family member. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Heart Arrest, Heart Arrest, Out-Of-Hospital, Cardiac Arrest
- What is being tested?
- Educational Intervention
- How many people
- 12,224 participants
- Where
- 1 siteCanada
- Study dates
- 14 Dec 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with prehospital cardiac arrest (absence of a detectable pulse, unresponsiveness, and apnea) occurring in the catchment area of any participating site during the active study period.
Who may be able to join
- We will enroll ALL patients with prehospital cardiac arrest (absence of a detectable pulse, unresponsiveness, and apnea):
- That are of presumed cardiac origin;
- That occur in the catchment area of our participating sites; and
- For which resuscitation is attempted by a bystander and/or the emergency responders.
Who cannot join
- Cardiac arrest witnessed by paramedics after their arrival (no opportunity for bystander intervention);
- Patients younger than 16 years of age (cardiac arrest usually respiratory and rare in this population);
- Patients who are "obviously dead";
- Trauma victims, including hanging and burns; or
- Patients with cardiac arrest clearly of other non-cardiac origin including drug overdose, carbon monoxide poisoning, drowning, exsanguination, electrocution, asphyxia, hypoxia related to respiratory disease, cerebrovascular accident and documented terminal illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Center Implementation of an Educational Program to Improve the Cardiac Arrest Diagnostic Accuracy of Ambulance Telecommunicators and Survival Outcomes for Sudden Cardiac Arrest Victims
Cardiac arrest is the number one cause of death in Canada. It is often the first symptom of cardiac disease for the victims. Eighty-five percent of victims collapse in their own home. Fifty percent collapse in the presence of a family member. Bystander cardiopulmonary resuscitation (CPR) can improve the chance to survive a cardiac arrest by three to four times, but needs to be started quickly. In most communities, less than 30% of victims receive CPR before the ambulance arrives. Currently, only 8% of cardiac arrest victims can leave the hospital alive.
Many things have been tried to improve the number of times people do CPR. So far, the only thing that really increased the number of times that someone did CPR is when 9-1-1 attendants started to give CPR instructions to callers over the phone. The only problem is that about 25% of cardiac arrest victims gasp for air in the first few minutes. This can fool the 9-1-1 callers and attendants into thinking that the victim is still alive.
Read more
The investigators have looked at all the studies on how to help 9-1-1 attendants to recognize abnormal breathing over the phone. The investigators have also learned what should be taught after finishing a large survey with 9-1-1 attendants from across Canada. This survey was done with the help of psychologists and other education experts. It measured the impact of attitudes, social pressures, and 9-1-1 attendants' perceived control over their ability to recognize abnormal breathing and cardiac arrest. Then the investigators developed a teaching tool which helped Ottawa 9-1-1 attendants recognize abnormal breathing. When they could do that, they could also recognize more cardiac arrest.
The main goal of this project is to use the tool developed in Ottawa in more centres to help 9-1-1 attendants save the lives of even more cardiac arrest victims across Canada.
- Conditions
- Heart Arrest, Heart Arrest, Out-Of-Hospital, Cardiac Arrest, Death, Sudden, Cardiac, Cardiac Arrest, Sudden, Cardiopulmonary Arrest
- Being tested
- Educational Intervention
- Keywords
- cardiac arrest, bystander cardiopulmonary resuscitation CPR, dispatch-assisted CPR instructions, agonal breathing
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Additional training provided to ambulance telecommunicators in participating sites to help increase recognition of agonal breathing in the presence of out-of-hospital cardiac arrest.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | Consecutive cases of out-of-hospital cardiac arrest occurring at participating sites, meeting the study eligibility criteria over a 12-month period preceding the implementation of the educational intervention for ambulance telecommunicators. | |
| Prospective | Consecutive cases of out-of-hospital cardiac arrest occurring at participating sites, meeting the study eligibility criteria over a 12-month period following the implementation of the educational intervention for ambulance telecommunicators. Receives: Other: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Accessing hospital medical records or coroner's reports, assess survival of cardiac arrest victim as being discharged alive from hospital.
Measured: Change between 12 month period before and after delivery of additional education to ambulance telecommunicators
Secondary outcomes (5)
Community Bystander Cardiopulmonary Resuscitation Rate
The first member of the emergency response team to arrive at the scene will document whether or not chest compressions have been initiated by someone prior to the arrival of the emergency team.
Measured: Change between 12 month period before and after delivery of additional education to ambulance telecommunicators
Telecommunication-assisted CPR instructions rate
By reviewing audio recordings, determine the cases where telecommunicator assistance led to delivery of chest compressions
Measured: Change between 12 month period before and after delivery of additional education to ambulance telecommunicators
Presence of agonal breathing
Document the presence or absence of agonal breathing through review of audio recording.
Measured: Change between 12 month period before and after delivery of additional education to ambulance telecommunicators
Cardiac arrest recognition rate
Measured: at time of event
Time intervals
call receipt to recognition of cardiac arrest, time to CPR instructions initiated
Measured: Change between 12 month period before and after delivery of additional education to ambulance telecommunicators
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start14 Dec 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, BC Emergency Health Services, Medacom Atlantic, Alberta Health services, Emergency Health Services Nova Scotia, Health PEI, Providence Health Care, British Columbia
- Responsible party
- Sponsor
- Investigators
- Christian Vaillancourt, MD, MSc, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894059
- Sponsor's protocol ID
- CRRF 1298
- Status last verified
- Oct 2024
- First submitted
- 19 Mar 2019
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vaillancourt C, Charette M, Naidoo S, Taljaard M, Church M, Hodges S, Leduc S, Christenson J, Cheskes S, Dainty K, Feldman M, Goldstein J, Tallon J, Helmer J, Sibley A, Spidel M, Blanchard I, Garland J, Cyr K, Brehaut J, Dorian P, Lacroix C, Zambon S, Thiruganasambandamoorthy V. Multi-centre implementation of an Educational program to improve the Cardiac Arrest diagnostic accuracy of ambulance Telecommunicators and survival outcomes for sudden cardiac arrest victims: the EduCATe study design and methodology. BMC Emerg Med. 2021 Mar 4;21(1):26. doi: 10.1186/s12873-021-00416-4.
PubMed 33663395
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Implementation of an Educational Program to Improve the Cardiac Arrest Diagnostic Accuracy of Ambulance Telecommunicators and Survival Outcomes for Sudden Cardiac Arrest Victims
- ClinicalTrials.gov ID
- NCT03894059
- Acronym / sponsor ID
- CRRF 1298
- Conditions
- Heart Arrest, Heart Arrest, Out-Of-Hospital, Cardiac Arrest, Death, Sudden, Cardiac, Cardiac Arrest, Sudden, Cardiopulmonary Arrest
- Keywords
- cardiac arrest, bystander cardiopulmonary resuscitation CPR, dispatch-assisted CPR instructions, agonal breathing
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 12,224 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, BC Emergency Health Services, Medacom Atlantic, Alberta Health services, Emergency Health Services Nova Scotia, Health PEI, Providence Health Care, British Columbia
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Mar 2019 (actual)
- 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.
Cardiac arrest is the number one cause of death in Canada. It is often the first symptom of cardiac disease for the victims. Eighty-five percent of victims collapse in their own home. Fifty percent collapse in the presence of a family member. Bystander cardiopulmonary resuscitation (CPR) can improve the chance to survive a cardiac arrest by three to four times, but needs to be started quickly. In most communities, less than 30% of victims receive CPR before the ambulance arrives. Currently, only 8% of cardiac arrest victims can leave the hospital alive.
Many things have been tried to improve the number of times people do CPR. So far, the only thing that really increased the number of times that someone did CPR is when 9-1-1 attendants started to give CPR instructions to callers over the phone. The only problem is that about 25% of cardiac arrest victims gasp for air in the first few minutes. This can fool the 9-1-1 callers and attendants into thinking that the victim is still alive.
The investigators have looked at all the studies on how to help 9-1-1 attendants to recognize abnormal breathing over the phone. The investigators have also learned what should be taught after finishing a large survey with 9-1-1 attendants from across Canada. This survey was done with the help of psychologists and other education experts. It measured the impact of attitudes, social pressures, and 9-1-1 attendants' perceived control over their ability to recognize abnormal breathing and cardiac arrest. Then the investigators developed a teaching tool which helped Ottawa 9-1-1 attendants recognize abnormal breathing. When they could do that, they could also recognize more cardiac arrest.
The main goal of this project is to use the tool developed in Ottawa in more centres to help 9-1-1 attendants save the lives of even more cardiac arrest victims across Canada.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | –Consecutive cases of out-of-hospital cardiac arrest occurring at participating sites, meeting the study eligibility criteria over a 12-month period preceding the implementation of the educational intervention for ambulance telecommunicators. |
| Prospective | – | Other: Educational InterventionConsecutive cases of out-of-hospital cardiac arrest occurring at participating sites, meeting the study eligibility criteria over a 12-month period following the implementation of the educational intervention for ambulance telecommunicators. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with prehospital cardiac arrest (absence of a detectable pulse, unresponsiveness, and apnea) occurring in the catchment area of any participating site during the active study period.
Key inclusion criteria (4 listed)
- We will enroll ALL patients with prehospital cardiac arrest (absence of a detectable pulse, unresponsiveness, and apnea):
- That are of presumed cardiac origin;
- That occur in the catchment area of our participating sites; and
- For which resuscitation is attempted by a bystander and/or the emergency responders.
Key exclusion criteria (5 listed)
- Cardiac arrest witnessed by paramedics after their arrival (no opportunity for bystander intervention);
- Patients younger than 16 years of age (cardiac arrest usually respiratory and rare in this population);
- Patients who are "obviously dead";
- Trauma victims, including hanging and burns; or
- Patients with cardiac arrest clearly of other non-cardiac origin including drug overdose, carbon monoxide poisoning, drowning, exsanguination, electrocution, asphyxia, hypoxia related to respiratory disease, cerebrovascular accident and documented terminal illness.
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 |
|---|---|---|
| Educational InterventionAdditional training provided to ambulance telecommunicators in participating sites to help increase recognition of agonal breathing in the presence of out-of-hospital cardiac arrest. | Other | Prospective |
Primary outcome
Overall Survival
Time frame: Change between 12 month period before and after delivery of additional education to ambulance telecommunicators
Accessing hospital medical records or coroner's reports, assess survival of cardiac arrest victim as being discharged alive from hospital.
5 secondary outcomes
Community Bystander Cardiopulmonary Resuscitation Rate
Time frame: Change between 12 month period before and after delivery of additional education to ambulance telecommunicators
Telecommunication-assisted CPR instructions rate
Time frame: Change between 12 month period before and after delivery of additional education to ambulance telecommunicators
Presence of agonal breathing
Time frame: Change between 12 month period before and after delivery of additional education to ambulance telecommunicators
Cardiac arrest recognition rate
Time frame: at time of event
Time intervals
Time frame: Change between 12 month period before and after delivery of additional education to ambulance telecommunicators
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Derived from this study: PubMed 33663395Vaillancourt C, Charette M, Naidoo S, Taljaard M, Church M, Hodges S, Leduc S, Christenson J, Cheskes S, Dainty K, Feldman M, Goldstein J, Tallon J, Helmer J, Sibley A, Spidel M, Blanchard I, Garland J, Cyr K, Brehaut J, Dorian P, Lacroix C, Zambon S, Thiruganasambandamoorthy V. Multi-centre implementation of an Educational program to improve the Cardiac Arrest diagnostic accuracy of ambulance Telecommunicators and survival outcomes for sudden cardiac arrest victims: the EduCATe study design and methodology. BMC Emerg Med. 2021 Mar 4;21(1):26. doi: 10.1186/s12873-021-00416-4.
- Individual participant dataSharing planned: Undecided
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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.
Christian Vaillancourt, MD, MSc principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Arrest and Heart Arrest, Out-Of-Hospital, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2024. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Overall Survival (time frame: Change between 12 month period before and after delivery of additional education to ambulance telecommunicators). 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 NCT03894059, 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 2024.