LUCAS Chest Compressor Versus Manual Chest Compression in Out-of-hospital Sudden Cardiac Arrest. LUCAT Trial

Study Overview
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Brief Summary
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The goal of this study is to show the superiority in survival at hospital admittance and in neurological outcome on hospital discharge of continuous mechanical chest compression using LUCAS device versus manual chest compressions in patients who suffered an out-of-hospital cardiac arrest.

Detailed Description
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The primary goals of the trial are: To show a survival increase at hospital admittance after out-of-hospital cardiac arrest of patients treated by continuous chest compressions LUCAS device compared with patients treated by manual chest compressions. To evaluate neurological outcome on hospital discharge, in two centres (Vall d'Hebron Hospital and Josep Trueta Hospital).

Official Title
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LUcas Continuous Chest Compressions in Out-of-hospital Cardiac Arrest Treatment. The LUCAT Trial

Conditions
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Sudden Cardiac Arrest

Intervention / Treatment
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* Device: LUCAS (Lund University Cardiac Assist Sysrem)
* Other: Manual chest compressions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: between 18 and 80 years , Suffering from NON traumatic or an unexpected SCA, SCA witnessed (seen, heard or monitored), Attended by an advanced support ambulance (served by doctor or nurse) in Barcelona city, or in the Girona or Lleida area Time between alarm-call to SEM 061 and reaching patient is less than 12 minutes. Exclusion Criteria: Biological signs of death Age under 18 or over 80 years Trauma caused cardio respiratory arrest (CRA), including hanging Secondary CRA or intoxication Return of spontaneous circulation previous to arrival of SEM's medical team Known pregnancy Inadequate size for LUCAS device Anything in the study that can delay treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LUCAS, Continuous chest compressions<br>Mechanical continuous chest compressions performed by LUCAS device (also during defibrillation) | Device: LUCAS (Lund University Cardiac Assist Sysrem)<br>* LUCAS device will be placed on patients suffering a cardiac arrest and continuous chest compressions will be performed, even while defibrillation is being applied<br>* Other names: Mechanical continuous chest compressions;|
| Active Comparator: Manual chest compressions<br>Manual chest compression is performed, chest compressions halted during defibrillation | Other: Manual chest compressions<br>* Manual CPR according to 2010 ERC guidelines will be performed<br>* Other names: Cardiopulmonary resuscitation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival at hospital admittance | The primary goal is to evaluate survival at hospital admittance of patients, after out-of hospital cardiac arrest treated by LUCAS device chest compressions, compared with those patients treated by manual chest compressions | 2 hours | 
| Survival on discharge from hospital (or 30 days if not applicable) in acceptable neurological state (CPC scale 1 or 2) | Evaluate the neurological outcome on hospital discharge, in two centres (Vall d'Hebron Hospital in Barcelona and Josep Trueta Hospital in Girona) 1 or 2 in Cerebral Performance Category | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration of spontaneous circulation | To compare the return of spontaneous circulation (ROSC) between both groups | 2 hours | 
| EndTidal CO2 values | To compare EndTidal CO2 values of patients during cardiopulmonary resuscitation (CPR)between boths study arms | Every four minutes during resuscitation maneuvers | 
| SOFA scale values | To compare the first three days, on hospital discharge SOFA scale value and the worse value obtained (date and hour) in patients who survived out-of-hospital SCA and weere brought to either Vall d'Hebron Hospital or Josep Trueta Hospital. | During the first three days and on hospital discharge | 
| Days before discharge from Intensive Care Unit (ICU) / Coronary Care Unit (CCU) | To compare days before discharge from Intensive Care Unit (ICU) / Coronary Care Unit (CCU) in patients who survived out-of-hospital SCA and were brought to either Vall d'Hebron Hospital or Josep Trueta Hospital | 30 days | 
| Metabolic (pH, lactate) and inflamatory (leukocytes, C reactive protein) parameters | To establish the differences in metabolic (pH, lactate) and inflamatory (leukocytes, C reactive protein) parameters in patients who survived out-of-hospital SCA and were brought to either Vall d'Hebron Hospital or Josep Trueta Hospital | During the first 24h, at >48h and at 5-7days | 
| Epidemiology of Out-of-Hospital Cardiac Arrest | To describe the epidemiology of out-of-hospital SCA in the cities of Barcelona, Girona and Lleida | 3 months | 
| To obtain a blood sample for genetic and biological studies | Blood samples from SCA survivors will be kept to perform biological studies. | 7 days | 
| Left ventricular function | To compare left ventricular function in patients who survived at out-of-hospital sudden cardiac arrest and were brought to either Vall d'Hebron Hospital or Josep Trueta Hospital | During the first 24h and during the 24h previous on hospital discharge or at two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Out-of-Hospital cardiac arrest (OHCA), Chest compressions, LUCAS device