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Real Time Amplitude Spectrum Area to Guide Defibrillation

NCT03237910 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2022-10-03

No results posted yet for this study

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.

Conditions

  • Out-Of-Hospital Cardiac Arrest
  • Ventricular Fibrillation

Interventions

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

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)

PROCEDURE

CPR

chest compressions and ventilations at a rate of 30:2

Sponsors & Collaborators

  • European Commission

    collaborator OTHER

  • Zoll Medical Corporation

    collaborator INDUSTRY

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Principal Investigators

  • Giuseppe Ristagno, MD, PhD · Istituto Di Ricerche Farmacologiche Mario Negri

  • Roberto Latini, MD · Istituto Di Ricerche Farmacologiche Mario Negri

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-28
Primary Completion
2021-07-26
Completion
2021-07-26
FDA Device
Yes

Countries

  • Italy

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03237910 on ClinicalTrials.gov