Out-of-hospital Cardiac ArrestOCARNCT01992419
Evaluation of Out-of-Hospital Cardiac Arrest Recognition by Non-physicians Dispatchers in a French Emergency Dispatch Call Center
An observational study of Out-of-hospital Cardiac Arrest, run by Fire Brigade Of Paris Emergency Medicine Dept at 1 site in France.
Trial summary
The purpose of this study is to measure an improvement in the detection rate of cardiac arrest (CA) in the Dispatch Center as a result of debriefings and repeated trainings for non-medical operators who receive emergency calls. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Out-of-hospital Cardiac Arrest
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Dec 2013
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: residents of Paris urban and suburban area
Who may be able to join
- Patient over 15 years old (adult morphology) suffering Out-of-hospital Cardiac Arrest before or during the call to the Dispatch Center
- Patient who benefited from the installation of a automated external defibrillator (AED) before or at the time of arrival of the rescuers on the scene
Who cannot join
- Patient conscious at the time of the call
- OHCA between the end of the phone call and the arrival of rescuers on site
- OHCA after the rescuers' arrival on site
- Dispatch Center alerted on "second line" from another institution (Police, SAMU), without the possibility of joining the first caller.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Cardiac Arrest Recognition by Non-physicians Dispatchers in the Paris Fire Brigade Emergency Call Dispatch Center
The purpose of this study is to measure an improvement in the detection rate of cardiac arrest (CA) in the Dispatch Center as a result of debriefings and repeated trainings for non-medical operators who receive emergency calls.
Read the detailed description
- . Justification The performance of phone-guided chest compressions is recommended to minimize the No Flow risk (1). Pre-arrival instructions and dispatch-assisted chest compressions are the first link in the chain of survival, determining the effectiveness of subsequent links. This first link is only possible if a prior detection of cardiac arrest was made. The Dispatch Center of the Fire Brigade of Paris receives more than 7,000 calls per day, including 8-10 calls for cardiac arrest. The establishment of specific training and experience feedback with emergency dispatchers should improve the detection of cardiac arrest (CA) by the same dispatchers.
- . Objectives The main objective is to measure an improvement in the detection rate of CA in the Dispatch Center as a result of debriefings and repeated trainings for non-medical operators who receive emergency calls. The secondary objective is to identify risk factors for CA non-detection by those emergency dispatchers.
- . Materials and Methods Experimental design: Observational prospective non-randomized controlled study. Type "before and after" study. Three observation periods are defined over a total period of 20 months. Different actions before and during each period: Period 1 Period 2 Period 3 Algorithm available to emergency dispatchers + + + New algorithm - - + Basic training for new operators - + + Daily briefing +/- +/- + Systematic Debreafing - - + Specific course before period - - + Table leaders training - - + Heads of room training - - + Period 1 is preceded and accompanied by the diffusion of a decision algorithm available to emergency dispatchers Period 2 is accompanied by:
- Short briefings, twice daily, in the presence of operators on duty that day
- Debriefing immediately after the call with some operators (but not systematically, depending on their availability). Period 3 is preceded by information to the Dispatch Center managers (heads of room and table leaders) and a short course about detection of CA (1 hour) for all operators. During this same period, a daily briefing for operators is established. The study is based on the three CA call periods' audio recordings For each period, all calls related to CA on the field were listened to and evaluated. Each call had a double audition:
- one audition by an instructor, responsible for managing calls in the Dispatch Center, and
- one audition by two emergency physicians experienced in the management of emergency calls. The second listening physician helped to verify, correct, and complete the variables collected during the first listening The variables collected during listening were:
- "detectability of the CA"
- detection or not of the CA
- the causes of non-detection
- the occurrence of dispatch-assisted chest compression
- the time between the start of the call and the time the operator pronounces the words "cardiopulmonary Resuscitation" or "CPR" or "chest compressions"
- the time between the start of the call and the first real chest compression
- causes for non-realization of chest compressions
- the presence or absence of a public defibrillator Other variables collected - Variables corresponding to the Utstein style:
- Epidemiological variables (age, sex, location, background)
- Specific backup system variables: time alert - use of an AED
- Specific first aid and medical management variables:
- type of rhythm detected by AED on the arrival of rescuers
- Success of first AED's shock (loss of ventricular fibrillaton (VF)5 seconds after shock)
- Number of shocks administered by the AED in the first 10 minutes of support by rescuers
- Recovery of a palpable pulse in the presence of rescuers, before the arrival of the medical team
- Resuscitation undertaken by the medical team YES/NO
- Injection of adrenaline: YES/NO
- Transport to the hospital with beating heart: YES/NO
- Released resuscitation YES/NO
- Survival to one year after the CA
- Quality of survival (CPC score) at 6 months, 1 year Main judgment criteria:
- Detection of CA by the emergency dispatcher:
- Detection is considered positive if the dispatcher formalized the presence of a CA , either on the software, or orally with the words "CPR" or "chest compression" at any time during the recorded call.
- It is considered negative if the dispatcher never suggested, neither orally nor in writing, the possibility of the presence of a CA.
- Secondary endpoints:
- Median time between the start of the emergency call and the pronunciation of the words "chest compressions," by the dispatcher
- Median time elapsed between the start of the emergency call and the actual start of chest compressions by caller
- Evaluation of the ventilation mode (hand on abdomen YES/NO, count the interval between two ventilatory movements YES/NO)
- . Statistics
Sample size We need 100 patients in each period group to observe an absolute 20% difference in the rate of CA detection, compared with the detection rate of the control group (period 1) estimated at 60%, with an alpha risk = 0.05 and an 80% power in bilateral situations.
For each period:
- Description of patient characteristics and outcome
Comparison of these periods:
- Comparison of detection rate between the reference period (P1) and each of the other periods
- The number of subjects included in each period allows the realization of a χ² test with an alpha risk retained at 5%
- Adjust the detection rate on the significantly different variables between the groups (age, sex, no flow, time of rescuer arrival)
- The period 1 and 2 will be grouped and compared with period 3.
In all periods:
- Search variables associated with successful detection
- Multivariate logistic regression analysis type
- Survival analysis.
- Description of the evolution of the detection rate over time
- Conditions
- Out-of-hospital Cardiac Arrest
- Keywords
- Out-of-hospital Cardiac arrest, telephone dispatch assisted resuscitation, cardiac arrest phone detection
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of CA Detected by the emergency dispatcher
Measured: one year
Secondary outcomes (1)
o Median time between the start of the emergency call and the pronunciation of the words "chest compressions," by the dispatcher
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-of-hospital Cardiac 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
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fire Brigade Of Paris Emergency Medicine Dept
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jost D., Fire Brigade Of Paris Emergency Medicine Dept
- Investigators
- Jean-Pierre TOURTIER, MDPhD Prof, Study chair, Paris Fire Brigade - Emergency Medical Dept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992419
- Sponsor's protocol ID
- bspp2013
- Acronym
- OCAR
- Status last verified
- Dec 2013
- First submitted
- 7 Nov 2013
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiac Arrest Recognition by Non-physicians Dispatchers in the Paris Fire Brigade Emergency Call Dispatch Center
- ClinicalTrials.gov ID
- NCT01992419
- Acronym / sponsor ID
- OCAR / bspp2013
- Conditions
- Out-of-hospital Cardiac Arrest
- Keywords
- Out-of-hospital Cardiac arrest, telephone dispatch assisted resuscitation, cardiac arrest phone detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fire Brigade Of Paris Emergency Medicine DeptUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Nov 2013 (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 measure an improvement in the detection rate of cardiac arrest (CA) in the Dispatch Center as a result of debriefings and repeated trainings for non-medical operators who receive emergency calls.
Detailed description
- . Justification The performance of phone-guided chest compressions is recommended to minimize the No Flow risk (1). Pre-arrival instructions and dispatch-assisted chest compressions are the first link in the chain of survival, determining the effectiveness of subsequent links. This first link is only possible if a prior detection of cardiac arrest was made. The Dispatch Center of the Fire Brigade of Paris receives more than 7,000 calls per day, including 8-10 calls for cardiac arrest. The establishment of specific training and experience feedback with emergency dispatchers should improve the detection of cardiac arrest (CA) by the same dispatchers.
- . Objectives The main objective is to measure an improvement in the detection rate of CA in the Dispatch Center as a result of debriefings and repeated trainings for non-medical operators who receive emergency calls. The secondary objective is to identify risk factors for CA non-detection by those emergency dispatchers.
- . Materials and Methods Experimental design: Observational prospective non-randomized controlled study. Type "before and after" study. Three observation periods are defined over a total period of 20 months. Different actions before and during each period: Period 1 Period 2 Period 3 Algorithm available to emergency dispatchers + + + New algorithm - - + Basic training for new operators - + + Daily briefing +/- +/- + Systematic Debreafing - - + Specific course before period - - + Table leaders training - - + Heads of room training - - + Period 1 is preceded and accompanied by the diffusion of a decision algorithm available to emergency dispatchers Period 2 is accompanied by:
- Short briefings, twice daily, in the presence of operators on duty that day
- Debriefing immediately after the call with some operators (but not systematically, depending on their availability). Period 3 is preceded by information to the Dispatch Center managers (heads of room and table leaders) and a short course about detection of CA (1 hour) for all operators. During this same period, a daily briefing for operators is established. The study is based on the three CA call periods' audio recordings For each period, all calls related to CA on the field were listened to and evaluated. Each call had a double audition:
- one audition by an instructor, responsible for managing calls in the Dispatch Center, and
- one audition by two emergency physicians experienced in the management of emergency calls. The second listening physician helped to verify, correct, and complete the variables collected during the first listening The variables collected during listening were:
- "detectability of the CA"
- detection or not of the CA
- the causes of non-detection
- the occurrence of dispatch-assisted chest compression
- the time between the start of the call and the time the operator pronounces the words "cardiopulmonary Resuscitation" or "CPR" or "chest compressions"
- the time between the start of the call and the first real chest compression
- causes for non-realization of chest compressions
- the presence or absence of a public defibrillator Other variables collected - Variables corresponding to the Utstein style:
- Epidemiological variables (age, sex, location, background)
- Specific backup system variables: time alert - use of an AED
- Specific first aid and medical management variables:
- type of rhythm detected by AED on the arrival of rescuers
- Success of first AED's shock (loss of ventricular fibrillaton (VF)5 seconds after shock)
- Number of shocks administered by the AED in the first 10 minutes of support by rescuers
- Recovery of a palpable pulse in the presence of rescuers, before the arrival of the medical team
- Resuscitation undertaken by the medical team YES/NO
- Injection of adrenaline: YES/NO
- Transport to the hospital with beating heart: YES/NO
- Released resuscitation YES/NO
- Survival to one year after the CA
- Quality of survival (CPC score) at 6 months, 1 year Main judgment criteria:
- Detection of CA by the emergency dispatcher:
- Detection is considered positive if the dispatcher formalized the presence of a CA , either on the software, or orally with the words "CPR" or "chest compression" at any time during the recorded call.
- It is considered negative if the dispatcher never suggested, neither orally nor in writing, the possibility of the presence of a CA.
- Secondary endpoints:
- Median time between the start of the emergency call and the pronunciation of the words "chest compressions," by the dispatcher
- Median time elapsed between the start of the emergency call and the actual start of chest compressions by caller
- Evaluation of the ventilation mode (hand on abdomen YES/NO, count the interval between two ventilatory movements YES/NO)
- . Statistics
Sample size We need 100 patients in each period group to observe an absolute 20% difference in the rate of CA detection, compared with the detection rate of the control group (period 1) estimated at 60%, with an alpha risk = 0.05 and an 80% power in bilateral situations.
For each period:
- Description of patient characteristics and outcome
Comparison of these periods:
- Comparison of detection rate between the reference period (P1) and each of the other periods
- The number of subjects included in each period allows the realization of a χ² test with an alpha risk retained at 5%
- Adjust the detection rate on the significantly different variables between the groups (age, sex, no flow, time of rescuer arrival)
- The period 1 and 2 will be grouped and compared with period 3.
In all periods:
- Search variables associated with successful detection
- Multivariate logistic regression analysis type
- Survival analysis.
- Description of the evolution of the detection rate over time
Study design
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- residents of Paris urban and suburban area
Key inclusion criteria (2 listed)
- Patient over 15 years old (adult morphology) suffering Out-of-hospital Cardiac Arrest before or during the call to the Dispatch Center
- Patient who benefited from the installation of a automated external defibrillator (AED) before or at the time of arrival of the rescuers on the scene
Key exclusion criteria (4 listed)
- Patient conscious at the time of the call
- OHCA between the end of the phone call and the arrival of rescuers on site
- OHCA after the rescuers' arrival on site
- Dispatch Center alerted on "second line" from another institution (Police, SAMU), without the possibility of joining the first caller.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ratio of CA Detected by the emergency dispatcher
Time frame: one year
1 secondary outcome
o Median time between the start of the emergency call and the pronunciation of the words "chest compressions," by the dispatcher
Time frame: one year
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 9 Dec 2013.
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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.
Jean-Pierre TOURTIER, MDPhD Prof study chair
Paris Fire Brigade - Emergency Medical Dept
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 Out-of-hospital Cardiac Arrest, run by Fire Brigade Of Paris Emergency Medicine Dept at 1 site in France.
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 2 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 9 Dec 2013. 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 France. 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?
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?
Ratio of CA Detected by the emergency dispatcher (time frame: one year). 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 9 Dec 2013.