Ventricular Tachycardia Clinical Trial
— DEFI-2022Official title:
Professional Rescuers Cardiopulmonary Resuscitation Performance After Implementation of a Defibrillation Algorithm for Early Treatment of Refibrillation, an Observational Study.
Verified date | May 2024 |
Source | French Defence Health Service |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In the Paris (France) Medical Emergency system, in the early phase of Out-of-hospital Cardiac Arrest (OHCA), the treatment of a Ventricular Fibrillation (VF) consists of delivering an External Electric Shock (EES) by a rescuer with the use of an Automated External Defibrillator (AED). This latter realizes a cardiac rhythm analysis every two minutes. This analysis requires that chest compressions (CC) be interrupted for a while. However, CC interruptions are potentially harmful due to the brain, and heart perfusions decrease. On the other hand, the recurrence of VF occurs mostly during the first minute after the shock, whereas the delay between 2 rhythm analysis is 2 minutes. The consequence is excessive time spent in VF, which is deleterious in terms of coronary and cerebral perfusion. The investigator implements a new AED algorithm whose operating principle is as follows. One minute after an EES administration, the AED realizes a cardiac rhythm analysis during which the rescuers do not need to interrupt the chest compressions (CC): this is called the rhythm analysis " in presence of CC" The detection of a VF " in presence of CC " needs to be confirmed, " in absence of CC " The CC's are therefore interrupted for new rhythm analysis. Once the presence of VF is approved, the AED proposes a shock to be administred The aim of the study Study Design: This is a prospective observational study. The eligibility criteria are as follows: - Patients in Out-Of-Hospital Cardiac Arrest. - Basic Life support care with an AED. The primary endpoint is the " chest-compression fraction (CCF) " that represents the CPR-time performance during the ten first minutes of BLS care ( or < 10 min in case of Return Of Spontaneus Circulation (ROSC))
Status | Completed |
Enrollment | 285 |
Est. completion date | April 2, 2022 |
Est. primary completion date | February 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | Inclusion Criteria: -Non-traumatic OHCA in adults, treated by a BLS team and connected to an AED equipped either with the 2017 or with the 2020 algorithm. Exclusion Criteria: - Use of AED in a pediatric mode - CPR administered in 15:2 mode - Patient already connected to another defibrillator at the arrival of the BLS Team - No shock advised by defibrillator at first analysis - Patient with a pacemaker Secondary Exclusion Criteria - Surviving patients' opposition to the use of their data. - Patients with unreadable electrocardiographic or impedance data. |
Country | Name | City | State |
---|---|---|---|
France | Paris Fire Brigade | Paris | Non, Merci |
Lead Sponsor | Collaborator |
---|---|
French Defence Health Service |
France,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Report on Chest Compression Fraction (CCf) | CCf is the length of time the patient receives chest compression/management time (describe as a %) | 10 minutes | |
Secondary | Report on Cardiopulmonary Resuscitation (CPR) parameters : CPR ratio | CPR ratio (time during which the patient receives chest compression and bag ventilation / total management time; describe as a %) | 10 minutes | |
Secondary | Report on Cardiopulmonary Resuscitation (CPR) parameters :Prompt CPR fraction | Prompt CPR fraction (duration between the two AED announcements "resume massage" and "interrupt massage"/ total management time; describe as a %) | 10 minutes | |
Secondary | Report on Cardiopulmonary Resuscitation (CPR) parameters:Maximal Hands-Off time | Maximal Hands-Off time (longest time frame without any CC; describe in seconds) | 10 minutes | |
Secondary | Report on Cardiopulmonary Resuscitation (CPR) parameters:Chest Compression Frequency | Chest Compression Frequency (i.e., measurement of the mobile frequency over 3 to 5 compressions; describe as number of chest compressions by minute) | 10 minutes | |
Secondary | Report on the diagnostic performance of the AED algorithms "during CC" and " in absence of CC" | Calculate Sensibility and Specificity | 10 minutes | |
Secondary | Report on the overall diagnostic performance resulting from the combination of the consecutive analyses " in presence of CC " and " in absence of CC" | Calculate Sensibility and Specificity | 10 minutes | |
Secondary | Report on five-second-post-shock rhythms and their incidence | asystole, pulseless electrical activity, ventricular tachycardia, ventricular fibrillation for "in absence of CC" analysis, at 5 seconds | 10 minutes | |
Secondary | Report on 60-second-post-shock rhythms and their incidence | asystole, pulseless electrical activity, ventricular tachycardia, ventricular fibrillation for "in absence of CC" analysis, at 60 seconds | 10 minutes | |
Secondary | Report on 120 second-post-shock rhythms and their incidence | asystole, pulseless electrical activity, ventricular tachycardia, ventricular fibrillation for "in absence of CC" analysis, at 120 seconds | 10 minutes | |
Secondary | Report on 15-second-post-shock rhythms and their incidence | asystole, pulseless electrical activity, ventricular tachycardia, ventricular fibrillation for "in absence of CC" analysis, at 15 seconds | 10 minutes | |
Secondary | Report on 30-second-post-shock rhythms and their incidence | asystole, pulseless electrical activity, ventricular tachycardia, ventricular fibrillation for "in absence of CC" analysis, at 30 seconds | 10 minutes | |
Secondary | Report on the number of electrical shocks (EES) delivered and the duration of the rhythmic storm | Total number of EES delivered (describe as a number) | 1 hour | |
Secondary | Report on the number of electrical shocks (EES) intended and the duration of the rhythmic storm | Ratio "number of EES intended / number of EES delivered" (describe as a ratio %) | 1 hour | |
Secondary | Report on the temporal distribution of electrical shocks (EES) and the duration of the rhythmic storm | EES temporal distribution per patient | 1 hour | |
Secondary | Report on the delay from start to end of cumulative VF episodes | The time period from the start of the first occurence of VF to to the ending of the last episode of ventricular fibrillation (VF) ( seconds) | 1 hour | |
Secondary | The time period from the AED-switch-on and the first EES (describe in seconds) | The time period from the AED-switch-on and the first EES (describe in seconds) | 1 hour | |
Secondary | The distribution over time of EES. | The distribution over time of EES. | 1 hour | |
Secondary | Outcomes - ROSC | Return Of Spontaneous Circulation (ROSC) (describe as a ratio of patients with ROSC / patients included) | 2 hours | |
Secondary | Outcomes - admitted alive at hospital | Survival to hospital admission (describe as a ratio of patients admitted beating heart to hospital / patients included) | 2 hours | |
Secondary | Outcomes - discharged from hospital | Survival at hospital discharge (describe as a ratio of patients discharged alive from hospital / patients included) | 1 month | |
Secondary | Compare Chest Compression Fraction (CCf) to Paris Fire Brigade 2017 historical data | CCf is the length of time the patient receives chest compression/management time (describe as a %) | 10 minutes | |
Secondary | Prompt CPR fraction (duration between the two AED announcements "resume massage" and "interrupt massage"/ total management time; describe as a %) | Prompt CPR fraction (duration between the two AED announcements "resume massage" and "interrupt massage"/ total management time; describe as a %) | 10 minutes | |
Secondary | CPR ratio (time during which the patient receives chest compression and bag ventilation / total management time; describe as a %) | CPR ratio (time during which the patient receives chest compression and bag ventilation / total management time; describe as a %) | 10 minutes | |
Secondary | Maximal Hands-Off time (longest time frame without any CC; describe in seconds) | Maximal Hands-Off time (longest time frame without any CC; describe in seconds) | 10 minutes | |
Secondary | Chest Compression Frequency (i.e., measurement of the mobile frequency over 3 to 5 compressions; describe as number of chest compressions by minute) | Chest Compression Frequency (i.e., measurement of the mobile frequency over 3 to 5 compressions; describe as number of chest compressions by minute) | 10 minutes | |
Secondary | Compare Sensibility and Specificity of AED algorithm "during CC" and "in absence of CC" to 2017 algorithm Sensibility and Specificity | Compare Sensibility and Specificity of AED algorithm "during CC" and "in absence of CC" to 2017 algorithm Sensibility and Specificity | 10 minutes | |
Secondary | Compare the overall diagnostic performance resulting from the combination of the consecutive analyses " in presence of CC " and " in absence of CC" to Paris Fire Brigade 2017 historical data | Compare the overall diagnostic performance resulting from the combination of the consecutive analyses " in presence of CC " and " in absence of CC" to Paris Fire Brigade 2017 algorithm Sensibility and Specificity | 10 minutes | |
Secondary | Compare post-shock rhythms and their incidence to Paris Fire Brigade 2017 historical data | Compare asystole, pulseless electrical activity, ventricular tachycardia, ventricular fibrillation incidence for "in presence of CC" analysis, at 5 seconds to Paris Fire Brigade 2017 differents rhythms incidences. | 10 minutes | |
Secondary | Compare post-shock rhythms and their incidence to Paris Fire Brigade 2017 historical data | Compare asystole, pulseless electrical activity, ventricular tachycardia, ventricular fibrillation incidence for "in absence of CC" analysis, at 60 seconds to Paris Fire Brigade 2017 differents rhythms incidences. | 10 minutes | |
Secondary | Compare post-shock rhythms and their incidence to Paris Fire Brigade 2017 historical data | Compare asystole, pulseless electrical activity, ventricular tachycardia, ventricular fibrillation incidence for "in absence of CC" analysis, at 120 seconds to Paris Fire Brigade 2017 differents rhythms incidences. | 10 minutes | |
Secondary | Compare post-shock rhythms and their incidence to Paris Fire Brigade 2017 historical data | Compare asystole, pulseless electrical activity, ventricular tachycardia, ventricular fibrillation incidence for "in absence of CC" analysis, at 5 seconds to Paris Fire Brigade 2017 differents rhythms incidences. | 10 minutes | |
Secondary | Compare number of electrical shocks (EES) and the duration of the rhythmic storm to Paris Fire Brigade 2017 historical data | Total number of EES delivered (describe as a number) compare to Paris Fire Brigade 2017 historical data | 10 minutes | |
Secondary | Compare number of electrical shocks (EES) and the duration of the rhythmic storm to Paris Fire Brigade 2017 historical data | EES temporal distribution per patient compare to Paris Fire Brigade 2017 historical data | 10 minutes | |
Secondary | Compare number of electrical shocks (EES) and the duration of the rhythmic storm to Paris Fire Brigade 2017 historical data | The time period from the start of the first to the end of the last ventricular fibrillation (VF) episode (describe in seconds) compare to Paris Fire Brigade 2017 historical data | 10 minutes | |
Secondary | Compare number of electrical shocks (EES) and the duration of the rhythmic storm to Paris Fire Brigade 2017 historical data | The time period from the AED-switch-on and the first EES (describe in seconds) compare to Paris Fire Brigade 2017 historical data | 10 minutes | |
Secondary | Compare number of electrical shocks (EES) and the duration of the rhythmic storm to Paris Fire Brigade 2017 historical data | Compare the distribution over time of EES.to Paris Fire Brigade 2017 historical data | 10 minutes | |
Secondary | Outcomes - ROSC | Compare return Of Spontaneous Circulation (ROSC) to Paris Fire Brigade 2017 historical data (describe as a ratio of patients with ROSC / patients included) | 1 hour | |
Secondary | Outcomes - admitted alive at hospital | Compare survival to hospital admission to Paris Fire Brigade 2017 historical data (describe as a ratio of patients admitted beating heart to hospital / patients included) | 2 hours | |
Secondary | Outcomes - hospital discharge | Compare survival at hospital discharge to Paris Fire Brigade 2017 historical data (describe as a ratio of patients discharged alive from hospital / patients included) | 1 month |
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