Real Time Amplitude Spectrum Area to Guide Defibrillation

Study Overview
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Brief Summary
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AMSA trial is a multicenter, randomized, controlled study in out-of-hospital cardiac arrest patients. The purpose of the study is to test the hypothesis that a real time AMSA analysis during CPR may predict the success of defibrillation and optimize the timing of defibrillation delivery. The primary end-point is the efficacy of the AMSA-CPR: termination of VF/VT with achievement of ROSC for an AMSA ≥ 15.5 mV-Hz All patients meeting inclusion/exclusion criteria and receiving cardiopulmonary resuscitation are randomized into two groups: AMSA-guided CPR or standard CPR. In the AMSA-CPR group, AMSA value suggests when the rescuer should deliver the defibrillation attempt; In the Standard-CPR group, the defibrillation is delivered based on the 2015 European Resuscitation Council (ERC) CPR guidelines.

Detailed Description
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In the AMSA-CPR intervention, upon arrival of the advanced life support (ALS) rescue team at the cardiac arrest scene and application of the defibrillatory pads to the patient's chest and power on of the defibrillator with the real time AMSA analysis: If AMSA is ≥ 15.5 mV-Hz, an immediate defibrillation is attempted, followed by CPR If AMSA is < 15.5 mV-Hz, defibrillation is not attempted and CPR is delivered During the 2-min cycle of CPR, AMSA is measured during pauses for ventilations (every 30 CC, approximately every 20/25 sec). If an AMSA value ≥ 15.5 mV-Hz is achieved prior to cycle completion, an immediate defibrillation is delivered (thus the defibrillation attempt is anticipated) After completion of the first 2-min CPR cycle: If AMSA is ≤ 6.5 mV-Hz, the defibrillation is not attempted but CPR is continued If AMSA is > 6.5 mV-Hz, an immediate defibrillation attempt is delivered, followed by CPR During the 2-min cycle of CPR, AMSA is measured during pauses for ventilations (every 30 CC, approximately every 20/25 sec). If an AMSA value ≥ 15.5 mV-Hz is achieved prior to cycle completion, an immediate defibrillation is delivered After completion of the second 2-min CPR cycle and till the end of the resuscitative intervention: • CPR is continued based on standard 2015 ERC guidelines (a defibrillation attempt every 2-min CPR cycles), except for the possibility to anticipate the defibrillation attempt if AMSA becomes ≥ 15.5 mV-Hz during the CPR cycle. In the standard CPR intervention, upon arrival of the ALS team at the cardiac arrest scene, and application of the defibrillatory pads to the patient's chest and power on of the defibrillator: • a defibrillation is immediately attempted and CPR is then started and continued for 2- min. Analysis of rhythm and subsequent defibrillation attempts are performed every 2-min CPR cycles. In both study groups, the quality of CC and ventilation is monitored in real time thought the feedback integrated into the defibrillator.

Official Title
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AMplitude Spectrum Area to Guide Defibrillation During Cardiopulmonary Resuscitation in Out-of-hospital Cardiac Arrest Patients

Conditions
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Out-Of-Hospital Cardiac Arrest, Ventricular Fibrillation

Intervention / Treatment
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* Diagnostic Test: AMSA
* Procedure: Defibrillation
* Procedure: CPR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients (age ≥ 18) suffering of out-of-hospital non traumatic cardiac arrest of presumably cardiac etiology with a presenting shockable rhythm requiring electrical defibrillation: Ventricular Fibrillation and pulseless Ventricular Tachycardia. Exclusion Criteria: age < 18 years old pregnancy cardiac arrest with a non-shockable rhythm (pulseless electrical activity and asystole) a defibrillation delivered by an AED prior to ALS arrival cardiac arrest of traumatic origin non-cardiac cause of cardiac arrest presumable irreversible death or known terminal illness at the beginning of ALS clinical death participation in another clinical or device trial within the previous 30 days refused informed consent to the use of data.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMSA-CPR<br>The professional rescuer decides to deliver the defibrillation attempt based on the AMSA value displayed in the defibrillator | Diagnostic Test: AMSA<br>* A non-invasive and real time VF (Amplitude Spectrum Area) AMSA analysis is performed during chest compression pauses for delivery of 2 ventilations, from the ECG acquired from the conventional defibrillatory pads<br>* Other names: VF waveform analysis;Procedure: Defibrillation<br>* delivery of the defibrillation is attempted to terminate VF either based on AMSA value (in the AMSA-CPR arm) or every 2-min CPR cycle as recommended by current guidelines (in the Standard-CPR arm)<br>* Other names: electric countershock;Procedure: CPR<br>* chest compressions and ventilations at a rate of 30:2<br>* Other names: resuscitation maneuvres;|
| Active Comparator: Standard-CPR<br>The defibrillation is delivered based on the 2015 European Resuscitation Council CPR guidelines | Procedure: Defibrillation<br>* delivery of the defibrillation is attempted to terminate VF either based on AMSA value (in the AMSA-CPR arm) or every 2-min CPR cycle as recommended by current guidelines (in the Standard-CPR arm)<br>* Other names: electric countershock;Procedure: CPR<br>* chest compressions and ventilations at a rate of 30:2<br>* Other names: resuscitation maneuvres;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return of spontaneous circulation (ROSC) | Termination of ventricular fibrillation with achievement of ROSC for an AMSA value ≥ 15.5 mV-Hz | At day 0: from date of initiation of the cardiopulmonary resuscitation (CPR) maneuvres up to ROSC or up to 1 hour of CPR (which comes first) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defibrillation attempts | Number of defibrillations to achieve ROSC | At day 0: from date of initiation of the cardiopulmonary resuscitation (CPR) maneuvres up to ROSC or up to 1 hour of CPR (which comes first) | 
| CPR duration | duration of CPR in minutes prior to achieve ROSC | At day 0: from date of initiation of the cardiopulmonary resuscitation (CPR) maneuvres up to ROSC or up to 1 hour of CPR (which comes first) | 
| Cardiac troponins | assessment of circulating levels of high sensitive cardiac troponin T in plasma as marker of cardiac injury | at 6 and 24 hours after ICU admission | 
| Short term survival | number of patients alive after initial resuscitation | at hospital admission and 24 hours after ROSC | 
| Long term survival | number of patients alive after initial resuscitation | at 1 and 6 months after ROSC | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amplitude spectrum area, defibrillation, waveform analysis, cardiac arrest, cardiopulmonary resuscitation