- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01992419
Evaluation of Out-of-Hospital Cardiac Arrest Recognition by Non-physicians Dispatchers in a French Emergency Dispatch Call Center (OCAR)
Evaluation of Cardiac Arrest Recognition by Non-physicians Dispatchers in the Paris Fire Brigade Emergency Call Dispatch Center
Descripción general del estudio
Estado
Condiciones
Descripción detallada
. 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
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Paris, Francia, 75017
- Paris Fire Brigade Emergency Dept
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
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
Exclusion Criteria:
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Ratio of CA Detected by the emergency dispatcher
Periodo de tiempo: one year
|
one year
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
o Median time between the start of the emergency call and the pronunciation of the words "chest compressions," by the dispatcher
Periodo de tiempo: one year
|
one year
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Median time elapsed between the start of the emergency call and the actual start of chest compressions by caller
Periodo de tiempo: one year
|
one year
|
|
Evaluation of the ventilation mode (hand on abdomen YES/NO, count the interval between two ventilatory movements YES/NO)
Periodo de tiempo: one year
|
, all calls related to Out -of-hospital Cardiac Arrest were registered , and in the days after, listened to and evaluated.
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one year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Jean-Pierre TOURTIER, MDPhD Prof, Paris Fire Brigade - Emergency Medical Dept
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- bspp2013
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