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Real Time Amplitude Spectrum Area to Guide Defibrillation

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03237910
Acronym
AMSA
Enrollment
31
Registered
2017-08-03
Start date
2019-04-28
Completion date
2021-07-26
Last updated
2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Out-Of-Hospital Cardiac Arrest, Ventricular Fibrillation

Keywords

amplitude spectrum area, defibrillation, waveform analysis, cardiopulmonary resuscitation, cardiac arrest

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.

Interventions

DIAGNOSTIC_TESTAMSA

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

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)

PROCEDURECPR

chest compressions and ventilations at a rate of 30:2

Sponsors

European Commission
CollaboratorOTHER
Zoll Medical Corporation
CollaboratorINDUSTRY
Mario Negri Institute for Pharmacological Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Return of spontaneous circulation (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)Termination of ventricular fibrillation with achievement of ROSC for an AMSA value ≥ 15.5 mV-Hz

Secondary

MeasureTime frameDescription
CPR durationAt 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 troponinsat 6 and 24 hours after ICU admissionassessment of circulating levels of high sensitive cardiac troponin T in plasma as marker of cardiac injury
Defibrillation attemptsAt 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
Short term survivalat hospital admission and 24 hours after ROSCnumber of patients alive after initial resuscitation
Long term survivalat 1 and 6 months after ROSCnumber of patients alive after initial resuscitation

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026