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Real Time Amplitude Spectrum Area to Guide Defibrillation (AMSA)

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ClinicalTrials.gov Identifier: NCT03237910
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : May 29, 2019
Sponsor:
Collaborators:
European Commission
Zoll Medical Corporation
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Out-Of-Hospital Cardiac Arrest Ventricular Fibrillation Diagnostic Test: AMSA Procedure: Defibrillation Procedure: CPR Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 398 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: AMplitude Spectrum Area to Guide Defibrillation During Cardiopulmonary Resuscitation in Out-of-hospital Cardiac Arrest Patients
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : March 31, 2021


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 Name: 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 Name: electric countershock

Procedure: CPR
chest compressions and ventilations at a rate of 30:2
Other Name: 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 Name: electric countershock

Procedure: CPR
chest compressions and ventilations at a rate of 30:2
Other Name: resuscitation maneuvres




Primary Outcome Measures :
  1. Return of spontaneous circulation (ROSC) [ Time Frame: 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 :
  1. Defibrillation attempts [ Time Frame: 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

  2. CPR duration [ Time Frame: 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

  3. Cardiac troponins [ Time Frame: 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

  4. Short term survival [ Time Frame: at hospital admission and 24 hours after ROSC ]
    number of patients alive after initial resuscitation

  5. Long term survival [ Time Frame: at 1 and 6 months after ROSC ]
    number of patients alive after initial resuscitation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237910


Contacts
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Contact: Giuseppe Ristagno, MD, PhD 3299738490 ext 4613 gristag@gmail.com
Contact: Francesca Fumagalli, MSc 023901 ext 4622 francesca.fumagalli@marionegri.it

Locations
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Italy
UOC Rianimazione-Emergenza Territoriale 118, Dipartimento di Emergenza, Ospedale Maggiore - AUSL di Bologna Recruiting
Bologna, Italy, 40124
Contact: Federico Semeraro, MD    051 4132009    fsemeraro2008@gmail.com   
Principal Investigator: Giovanni Gordini, MD         
SOREU Metropolitana - AREU ASST, Grande Ospedale Metropolitano Niguarda Recruiting
Milano, Italy, 20162
Contact: Giovanni Sesana, MD    0264443356    aatmi@areu.lombardia.it   
Principal Investigator: Giovanni Sesana, MD         
SSD 118, Dipartimento di Medicina Perioperatoria Terapia Intensiva ed Emergenza. Azienda Sanitaria Universitaria Integrata di Trieste Not yet recruiting
Trieste, Italy, 34128
Contact: Umberto Lucangelo, MD    040 3995090    u.lucangelo@fmc.units.it   
Principal Investigator: Alberto Peratoner, MD         
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
European Commission
Zoll Medical Corporation
Investigators
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Study Chair: Giuseppe Ristagno, MD, PhD Istituto Di Ricerche Farmacologiche Mario Negri
Study Chair: Roberto Latini, MD Istituto Di Ricerche Farmacologiche Mario Negri

Additional Information:
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Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT03237910     History of Changes
Other Study ID Numbers: IRFMN-7167-7429
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Mario Negri Institute for Pharmacological Research:
amplitude spectrum area
defibrillation
waveform analysis
cardiopulmonary resuscitation
cardiac arrest

Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Ventricular Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes