NCT03237910

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Mario Negri Institute for Pharmacological Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Out-Of-Hospital Cardiac Arrest
• Ventricular Fibrillation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-04-28
• Primary completion: 2021-07-26
• Completion: 2021-07-26
• First posted: 2017-08-03
• Last updated: 2022-10-03

Locations

2 sites across 1 country: Italy

Regulatory

• FDA-regulated device study