Real Time Amplitude Spectrum Area to Guide Defibrillation (AMSA)

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

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.

Study Overview

• Status: Terminated
• Conditions: Ventricular Fibrillation; Out-Of-Hospital Cardiac Arrest
• Intervention / Treatment: Diagnostic test: AMSA; Procedure: Defibrillation; Procedure: CPR

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40124
    • UOC Rianimazione-Emergenza Territoriale 118, Dipartimento di Emergenza, Ospedale Maggiore - AUSL di Bologna
  • Milano, Italy, 20162
    • SOREU Metropolitana - AREU ASST, Grande Ospedale Metropolitano Niguarda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AMSA-CPR; The professional rescuer decides to deliver the defibrillation attempt based on the AMSA value displayed in the defibrillator	Diagnostic test: AMSA; 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; Other Names: VF waveform analysis; Procedure: Defibrillation; 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); Other Names: electric countershock; Procedure: CPR; chest compressions and ventilations at a rate of 30:2; Other Names: resuscitation maneuvres
Active Comparator: Standard-CPR; The defibrillation is delivered based on the 2015 European Resuscitation Council CPR guidelines	Procedure: Defibrillation; 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); Other Names: electric countershock; Procedure: CPR; chest compressions and ventilations at a rate of 30:2; Other Names: resuscitation maneuvres

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mario Negri Institute for Pharmacological Research
• Collaborators: European Commission; Zoll Medical Corporation
• Investigators: Study Chair: Giuseppe Ristagno, MD, PhD, Istituto Di Ricerche Farmacologiche Mario Negri

Publications and helpful links

Helpful Links

• EU Framework Horizon 2020 Programme under grant agreement no. 733381: European Sudden Cardiac Arrest network: towards Prevention, Education and New Treatment (ESCAPE-NET)
• ESCAPE NET in ERC website
• ESCAPE NET in EHRA website

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2019
• Primary Completion (Actual): July 26, 2021
• Study Completion (Actual): July 26, 2021

Study Registration Dates

• First Submitted: July 21, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: cardiac arrest; cardiopulmonary resuscitation; defibrillation; amplitude spectrum area; waveform analysis
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Arrest; Ventricular Fibrillation; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: IRFMN-7167-7429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes