Real Time Amplitude Spectrum Area to Guide Defibrillation
- Conditions
- Ventricular FibrillationOut-Of-Hospital Cardiac Arrest
- Interventions
- Diagnostic Test: AMSAProcedure: DefibrillationProcedure: CPR
- Registration Number
- NCT03237910
- Lead Sponsor
- Mario Negri Institute for Pharmacological Research
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 31
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AMSA-CPR Defibrillation The professional rescuer decides to deliver the defibrillation attempt based on the AMSA value displayed in the defibrillator AMSA-CPR AMSA The professional rescuer decides to deliver the defibrillation attempt based on the AMSA value displayed in the defibrillator Standard-CPR CPR The defibrillation is delivered based on the 2015 European Resuscitation Council CPR guidelines AMSA-CPR CPR The professional rescuer decides to deliver the defibrillation attempt based on the AMSA value displayed in the defibrillator Standard-CPR Defibrillation The defibrillation is delivered based on the 2015 European Resuscitation Council CPR guidelines
- Primary Outcome Measures
Name Time Method Return of spontaneous circulation (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) Termination of ventricular fibrillation with achievement of ROSC for an AMSA value ≥ 15.5 mV-Hz
- Secondary Outcome Measures
Name Time Method CPR duration 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) duration of CPR in minutes prior to achieve ROSC
Cardiac troponins at 6 and 24 hours after ICU admission assessment of circulating levels of high sensitive cardiac troponin T in plasma as marker of cardiac injury
Long term survival at 1 and 6 months after ROSC number of patients alive after initial resuscitation
Defibrillation attempts 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) Number of defibrillations to achieve ROSC
Short term survival at hospital admission and 24 hours after ROSC number of patients alive after initial resuscitation
Trial Locations
- Locations (2)
UOC Rianimazione-Emergenza Territoriale 118, Dipartimento di Emergenza, Ospedale Maggiore - AUSL di Bologna
🇮🇹Bologna, Italy
SOREU Metropolitana - AREU ASST, Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Italy