Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139542
Status:
COMPLETED
Last Update Posted:
2009-05-11
First Post:
2005-08-29
Brief Title:
AED Use in Out-of-Hospital Cardiac Arrest A New Algorithm Named One Shock Per Minute
Sponsor:
Fire Brigade Of Paris Emergency Medicine Dept
Organization:
Fire Brigade Of Paris Emergency Medicine Dept
Study Overview
Official Title:
Automated External Defibrillator AED Use in Out-of-Hospital Cardiac Arrest A New Algorithm Named One Shock Per Minute
Status:
COMPLETED
Status Verified Date:
2009-05
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:
DEFI2005
Brief Summary:
The aim of the trial is to evaluate a new AED algorithm that proposes a new timeline between the time devoted to administer a defibrillation shock and the time devoted to chest compressions
The researchers propose to decrease the periods of interruption of cardiopulmonary resuscitation CPR while keeping the principle of early defibrillation
The researchers propose to decrease the periods of interruption of cardiopulmonary resuscitation CPR while keeping the principle of early defibrillation
Detailed Description:
Early use of semi-automated external defibrillators AED by Emergency Care teams in out-of-hospital cardiac arrest OHCA has been correlated with a significant gain in sequelae-free survival The AED is programmed with an algorithm based recommended guidelines
We will test a new algorithm that takes into account recent findings in pathophysiology
Patients presenting with cardiovascular and pulmonary arrest treated by the BSPP Emergency Care who meet inclusion criterion are proposed for inclusion in the trial
The aim of the trial is to evaluate a new AED algorithm that proposes a new timeline between the time devoted to administer a defibrillation shock and the time devoted to chest compressions
The new algorithm is entitled one shock per minute Use of this algorithm should validate several hypotheses
the importance of administering cardiac massage and artificial ventilation CPR prior to initiation of electrical shock treatment
the importance of continuing CPR immediately following electrical shock treatment
the importance of reducing time between CPR procedures to a minimum
the fact that three successive electrical shocks are of no therapeutic benefit
We want to compare the control algorithm with the new one titled one shock per minute for shocked patients
The sample size of this trial was calculated to provide a power of 85 and a type 1 error rate of alpha 00294 for detecting an 11 increase in the rate of hospital admission from its historical rate of 34 to a new rate of 45 One interim analysis was planned with the stopping boundary alpha 00294 This required inclusion of 430 patients in each group
The primary endpoint is defined as the admission of the patient alive at the hospital
The secondary endpoints are defined as following
- Detection of Palpable Carotid Pulse ROSC within the first 8 minutes after the connection of the AED The other secondary endpoint is survival to one year
Concerning patients that do not receive shocks
They represent a priori 82 of the patients The absolute number is a priori 3940 that is to say 1970 in both two groups
They will be used for an advanced observational descriptive study to establish hypothesis for future studiesThe same primary and secondary endpoints will be evaluated for them
Among these patients not shocked the algorithm foresees 60 seconds of CPR for the Control Group and 90 seconds for the Trial Group This setting relies on the hypothesis that increasing the time dedicated to chest compressions will increase the probability of return of a palpable pulse ROSC even for patients who do not fibrillate
Statistical analysis will be completed by Hôpital dInstruction des Armées BEGIN - Epidemiology department
We propose a comparison using the Chi square test for qualitative variables Students t test for quantitative variables completion of a logistics model to analyze prognostic factors as well as the proportional hazards model for survival analysis Tests will be bilateral significant p 0029 if we consider one intermediate analysis
Overall analysis strategy will be defined and completed by the Epidemiology department of Hôpital dInstruction des Armées BEGIN
We will test a new algorithm that takes into account recent findings in pathophysiology
Patients presenting with cardiovascular and pulmonary arrest treated by the BSPP Emergency Care who meet inclusion criterion are proposed for inclusion in the trial
The aim of the trial is to evaluate a new AED algorithm that proposes a new timeline between the time devoted to administer a defibrillation shock and the time devoted to chest compressions
The new algorithm is entitled one shock per minute Use of this algorithm should validate several hypotheses
the importance of administering cardiac massage and artificial ventilation CPR prior to initiation of electrical shock treatment
the importance of continuing CPR immediately following electrical shock treatment
the importance of reducing time between CPR procedures to a minimum
the fact that three successive electrical shocks are of no therapeutic benefit
We want to compare the control algorithm with the new one titled one shock per minute for shocked patients
The sample size of this trial was calculated to provide a power of 85 and a type 1 error rate of alpha 00294 for detecting an 11 increase in the rate of hospital admission from its historical rate of 34 to a new rate of 45 One interim analysis was planned with the stopping boundary alpha 00294 This required inclusion of 430 patients in each group
The primary endpoint is defined as the admission of the patient alive at the hospital
The secondary endpoints are defined as following
- Detection of Palpable Carotid Pulse ROSC within the first 8 minutes after the connection of the AED The other secondary endpoint is survival to one year
Concerning patients that do not receive shocks
They represent a priori 82 of the patients The absolute number is a priori 3940 that is to say 1970 in both two groups
They will be used for an advanced observational descriptive study to establish hypothesis for future studiesThe same primary and secondary endpoints will be evaluated for them
Among these patients not shocked the algorithm foresees 60 seconds of CPR for the Control Group and 90 seconds for the Trial Group This setting relies on the hypothesis that increasing the time dedicated to chest compressions will increase the probability of return of a palpable pulse ROSC even for patients who do not fibrillate
Statistical analysis will be completed by Hôpital dInstruction des Armées BEGIN - Epidemiology department
We propose a comparison using the Chi square test for qualitative variables Students t test for quantitative variables completion of a logistics model to analyze prognostic factors as well as the proportional hazards model for survival analysis Tests will be bilateral significant p 0029 if we consider one intermediate analysis
Overall analysis strategy will be defined and completed by the Epidemiology department of Hôpital dInstruction des Armées BEGIN
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None