Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Real Time Amplitude Spectrum Area to Guide Defibrillation (AMSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE July 21, 2017
First Posted Date  ICMJE August 3, 2017
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03237910 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2017)
  • 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
  • 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
  • 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
  • Short term survival [ Time Frame: at hospital admission and 24 hours after ROSC ]
    number of patients alive after initial resuscitation
  • Long term survival [ Time Frame: at 1 and 6 months after ROSC ]
    number of patients alive after initial resuscitation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Real Time Amplitude Spectrum Area to Guide Defibrillation
Official Title  ICMJE AMplitude Spectrum Area to Guide Defibrillation During Cardiopulmonary Resuscitation in Out-of-hospital Cardiac Arrest Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Out-Of-Hospital Cardiac Arrest
  • Ventricular Fibrillation
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: AMSA-CPR
    The professional rescuer decides to deliver the defibrillation attempt based on the AMSA value displayed in the defibrillator
    Interventions:
    • Diagnostic Test: AMSA
    • Procedure: Defibrillation
    • Procedure: CPR
  • Active Comparator: Standard-CPR
    The defibrillation is delivered based on the 2015 European Resuscitation Council CPR guidelines
    Interventions:
    • Procedure: Defibrillation
    • Procedure: CPR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 22, 2018)
398
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2017)
412
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Giuseppe Ristagno, MD, PhD 3299738490 ext 4613 gristag@gmail.com
Contact: Francesca Fumagalli, MSc 023901 ext 4622 francesca.fumagalli@marionegri.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03237910
Other Study ID Numbers  ICMJE IRFMN-7167-7429
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mario Negri Institute for Pharmacological Research
Study Sponsor  ICMJE Mario Negri Institute for Pharmacological Research
Collaborators  ICMJE
  • European Commission
  • Zoll Medical Corporation
Investigators  ICMJE
Study Chair: Giuseppe Ristagno, MD, PhD Istituto Di Ricerche Farmacologiche Mario Negri
Study Chair: Roberto Latini, MD Istituto Di Ricerche Farmacologiche Mario Negri
PRS Account Mario Negri Institute for Pharmacological Research
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP