Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04691089
Status:
COMPLETED
Last Update Posted:
2024-05-30
First Post:
2020-10-31
Brief Title:
Cardiopulmonary Resuscitation Performance of Professional Rescuers With a New Defibrillation Algorithm
Sponsor:
French Defence Health Service
Organization:
French Defence Health Service
Study Overview
Official Title:
Professional Rescuers Cardiopulmonary Resuscitation Performance After Implementation of a Defibrillation Algorithm for Early Treatment of Refibrillation an Observational Study
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEFI-2022
Brief Summary:
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 CCs 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
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 CCs 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
Detailed Description:
BACKGROUND
For Out-Of-Hospital Cardiac Arrest OHCA patients suffering from ventricular fibrillation VF or ventricular tachycardia VT BLS care consists of administering external electric shocks EES and cardiopulmonary resuscitation CPR However despite successful defibrillation VF recurs in 50 of cases Rescuers are forced to repeat EES as often as needed without the recommendations specifying a maximum number
International guidelines recommend a 2-min CPR time between 2 rhythm analysis that means one shock every 2 min Since refibrillation occurs mostly during the first-minute post-shock the patient will have to wait until the end of the 2 minutes before receiving the next EES During that time the chest compressions CC provide a reduced fraction of physiologic blood flow
The new AED algorithm provides the following changes
After a 60-second post-shock CPR-period the AED performs an analysis in presence of CC ie without CC interruption is performed
Each time the AED detects a VF in presence of CC the algorithm requires the CC to be interrupted to perform an analysis in absence of CC to confirm the rhythm shockability
Analyses in presence of CC are triggered every minute possibly followed or not by an analysis in absence of CC
at least the algorithm performs an analysis in absence of CC systematically every 2 minutes
This new algorithm fits in between two historical CPR algorithms used in western medical systems - the one-minute and the two-minute CPR cycle- depending on the rhythm shockability detected in presence of CC
OBJECTIVES
The main objective is to measure the CC fraction during the ten first minutes of Fire Fighter BLS care in OHCA
The secondary objectives
1 Report on the available CPR quality parameters CC frequency hands-off maximum
2 Report on the AEDs diagnostic performance when analyzing the rhythm in presence of CC
3 Report on the AEDs diagnostic performance when analyzing the rhythm in absence of CC
4 Report on the overall AEDs diagnostic performance that results from the combination of two consecutive analyses in presence of CC and in absence of CC
5 Report on post-shock rhythms and their incidence
6 Report on the number of EES per patient
7 Report on the time distribution for the shocks administered per-patient to describe the rhythmic storm
8 Report on the incidence of Return Of Spontaneous Circulation ROSC survival at hospital admission and survival at hospital discharge
9 Compare these reports to a historical cohort 2017
METHOD
This is a prospective observational study
The observation window is limited to CPR cycles within the first 10 minutes of BLS care or less if ROSC is presumed
The choice of 10 minutes is intended to observe the BLS teams action without interfering with the ALS team that arrives later
The three following criteria define a presumptive ROSC
1 presence of QRS complexes of broadly similar morphology
2 synchronous impedance curve variation with the QRS complexes indicating intrathoracic movement in that case cardiac mechanical activity
3 no on-going CC
A CPR cycle is defined by the delay between two in absence of CC analyses
The study does not imply any change in current practice There is no planned interim analysis
All consecutive participants with inclusion criteria and no exclusion criteria will be analyzed
STUDY SIZE
The sample size was calculated to perform a non-inferiority analysis first followed by a superiority test if non-inferiority was demonstrated
Non-inferiority test The formula for calculating the required sample size in each group is based on a well-established statistical methodology designed for comparing two means in the context of a non-inferiority test
n Z α2 Z β2 X σ12 σ22 μ1- μ2 - δ2
With
Sample size n the number of subjects required in each group
α risk Initially set at 0025 this value is adjusted to account for multiple hypothesis testing by applying the Bonferroni correction
Power 1- β Established at 90
Expected mean difference This value is set to zero for this study
σ Standard Deviation The value for each group has been set to 17
δ Non-Inferiority Margin This margin is set at 5 an arbitrary value considered the maximal loss of effect inferiority that would be clinically acceptable when comparing CCF 2021 with CCF 2017
After the calculations the required sample size was 208 subjects for each group involved in the non-inferiority testing
Superiority test Should the non-inferiority hypothesis not be rejected the study design allows for a subsequent superiority test to be conducted
For superiority the investigators use the formula
n Z α2 Z β2 X σ12 σ22 μ1- μ22
With
Z α2 the Z value for an alpha2 significance level
Z β the Z value for a 1-beta power
σ12 and σ22 the variances of the two groups
μ1 and μ2 the means of the two groups
For α risk 0025 Bonferroni correction a power established at 90 a standard deviation of 17 and a detectable difference between the two groups of 5 the required sample size was 256 subjects for each group involved in the superiority testing STATA sampsi 65 70 SD17 alpha0025 To account for a 10 loss of subjects the number of patients was increased to 282 rounded up to 285 per group ie a total of 570 patients
To observe 285 shockable patients the investigators estimate the observation time required to be one year
Note that this same number of patients will be sufficient to detect an absolute 10 difference with an alpha risk of 5 and a power of 90 between patients in the 2017 group and patients in the 2020 group with regard to the secondary endpoint Survival at hospital admission
INTERRUPTION OR STOPPING OF THE STUDY
The sponsor has the responsibility to report to the national health authority any serious and unexpected adverse events attributable to the new AED algorithm
RISKS
A full report on the risks the description of incidents accidents and adverse events will be the subject of a chapter in the results section and also in the discussion
FINANCING
Funding for the study is provided by the Paris Fire Brigade promoter following acceptance of the survey under French policy for clinical research projects
DISCUSSION
The study will report on the CC fraction of an AED algorithm designed to analyze under CC
For Out-Of-Hospital Cardiac Arrest OHCA patients suffering from ventricular fibrillation VF or ventricular tachycardia VT BLS care consists of administering external electric shocks EES and cardiopulmonary resuscitation CPR However despite successful defibrillation VF recurs in 50 of cases Rescuers are forced to repeat EES as often as needed without the recommendations specifying a maximum number
International guidelines recommend a 2-min CPR time between 2 rhythm analysis that means one shock every 2 min Since refibrillation occurs mostly during the first-minute post-shock the patient will have to wait until the end of the 2 minutes before receiving the next EES During that time the chest compressions CC provide a reduced fraction of physiologic blood flow
The new AED algorithm provides the following changes
After a 60-second post-shock CPR-period the AED performs an analysis in presence of CC ie without CC interruption is performed
Each time the AED detects a VF in presence of CC the algorithm requires the CC to be interrupted to perform an analysis in absence of CC to confirm the rhythm shockability
Analyses in presence of CC are triggered every minute possibly followed or not by an analysis in absence of CC
at least the algorithm performs an analysis in absence of CC systematically every 2 minutes
This new algorithm fits in between two historical CPR algorithms used in western medical systems - the one-minute and the two-minute CPR cycle- depending on the rhythm shockability detected in presence of CC
OBJECTIVES
The main objective is to measure the CC fraction during the ten first minutes of Fire Fighter BLS care in OHCA
The secondary objectives
1 Report on the available CPR quality parameters CC frequency hands-off maximum
2 Report on the AEDs diagnostic performance when analyzing the rhythm in presence of CC
3 Report on the AEDs diagnostic performance when analyzing the rhythm in absence of CC
4 Report on the overall AEDs diagnostic performance that results from the combination of two consecutive analyses in presence of CC and in absence of CC
5 Report on post-shock rhythms and their incidence
6 Report on the number of EES per patient
7 Report on the time distribution for the shocks administered per-patient to describe the rhythmic storm
8 Report on the incidence of Return Of Spontaneous Circulation ROSC survival at hospital admission and survival at hospital discharge
9 Compare these reports to a historical cohort 2017
METHOD
This is a prospective observational study
The observation window is limited to CPR cycles within the first 10 minutes of BLS care or less if ROSC is presumed
The choice of 10 minutes is intended to observe the BLS teams action without interfering with the ALS team that arrives later
The three following criteria define a presumptive ROSC
1 presence of QRS complexes of broadly similar morphology
2 synchronous impedance curve variation with the QRS complexes indicating intrathoracic movement in that case cardiac mechanical activity
3 no on-going CC
A CPR cycle is defined by the delay between two in absence of CC analyses
The study does not imply any change in current practice There is no planned interim analysis
All consecutive participants with inclusion criteria and no exclusion criteria will be analyzed
STUDY SIZE
The sample size was calculated to perform a non-inferiority analysis first followed by a superiority test if non-inferiority was demonstrated
Non-inferiority test The formula for calculating the required sample size in each group is based on a well-established statistical methodology designed for comparing two means in the context of a non-inferiority test
n Z α2 Z β2 X σ12 σ22 μ1- μ2 - δ2
With
Sample size n the number of subjects required in each group
α risk Initially set at 0025 this value is adjusted to account for multiple hypothesis testing by applying the Bonferroni correction
Power 1- β Established at 90
Expected mean difference This value is set to zero for this study
σ Standard Deviation The value for each group has been set to 17
δ Non-Inferiority Margin This margin is set at 5 an arbitrary value considered the maximal loss of effect inferiority that would be clinically acceptable when comparing CCF 2021 with CCF 2017
After the calculations the required sample size was 208 subjects for each group involved in the non-inferiority testing
Superiority test Should the non-inferiority hypothesis not be rejected the study design allows for a subsequent superiority test to be conducted
For superiority the investigators use the formula
n Z α2 Z β2 X σ12 σ22 μ1- μ22
With
Z α2 the Z value for an alpha2 significance level
Z β the Z value for a 1-beta power
σ12 and σ22 the variances of the two groups
μ1 and μ2 the means of the two groups
For α risk 0025 Bonferroni correction a power established at 90 a standard deviation of 17 and a detectable difference between the two groups of 5 the required sample size was 256 subjects for each group involved in the superiority testing STATA sampsi 65 70 SD17 alpha0025 To account for a 10 loss of subjects the number of patients was increased to 282 rounded up to 285 per group ie a total of 570 patients
To observe 285 shockable patients the investigators estimate the observation time required to be one year
Note that this same number of patients will be sufficient to detect an absolute 10 difference with an alpha risk of 5 and a power of 90 between patients in the 2017 group and patients in the 2020 group with regard to the secondary endpoint Survival at hospital admission
INTERRUPTION OR STOPPING OF THE STUDY
The sponsor has the responsibility to report to the national health authority any serious and unexpected adverse events attributable to the new AED algorithm
RISKS
A full report on the risks the description of incidents accidents and adverse events will be the subject of a chapter in the results section and also in the discussion
FINANCING
Funding for the study is provided by the Paris Fire Brigade promoter following acceptance of the survey under French policy for clinical research projects
DISCUSSION
The study will report on the CC fraction of an AED algorithm designed to analyze under CC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None