Real Time Amplitude Spectrum Area to Guide Defibrillation (AMSA)

Mario Negri Institute for Pharmacological Research

Status: Terminated

Conditions: Out-Of-Hospital Cardiac Arrest; Ventricular Fibrillation

Treatments: Diagnostic Test: AMSA; Procedure: Defibrillation; Procedure: CPR

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03237910

IRFMN-7167-7429

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 2 patient groups

AMSA-CPR

Experimental group

Description:

The professional rescuer decides to deliver the defibrillation attempt based on the AMSA value displayed in the defibrillator

Treatment:

Procedure: CPR

Procedure: Defibrillation

Diagnostic Test: AMSA

Standard-CPR

Active Comparator group

Description:

The defibrillation is delivered based on the 2015 European Resuscitation Council CPR guidelines

Treatment:

Procedure: CPR

Procedure: Defibrillation