Sudden Cardiac Arrest
Conditions
Keywords
Out-of-Hospital cardiac arrest (OHCA), Chest compressions, LUCAS device
Brief summary
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
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).
Interventions
DEVICELUCAS (Lund University Cardiac Assist Sysrem)
LUCAS device will be placed on patients suffering a cardiac arrest and continuous chest compressions will be performed, even while defibrillation is being applied
Manual CPR according to 2010 ERC guidelines will be performed
Sponsors
Hospital Vall d'Hebron
Sistema d'Emergències Mèdiques
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival at hospital admittance | 2 hours | 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 |
| Survival on discharge from hospital (or 30 days if not applicable) in acceptable neurological state (CPC scale 1 or 2) | 30 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SOFA scale values | During the first three days and on hospital discharge | 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. |
| Days before discharge from Intensive Care Unit (ICU) / Coronary Care Unit (CCU) | 30 days | 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 |
| Metabolic (pH, lactate) and inflamatory (leukocytes, C reactive protein) parameters | During the first 24h, at >48h and at 5-7days | 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 |
| Restoration of spontaneous circulation | 2 hours | To compare the return of spontaneous circulation (ROSC) between both groups |
| To obtain a blood sample for genetic and biological studies | 7 days | Blood samples from SCA survivors will be kept to perform biological studies. |
| Left ventricular function | During the first 24h and during the 24h previous on hospital discharge or at two months | 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 |
| Epidemiology of Out-of-Hospital Cardiac Arrest | 3 months | To describe the epidemiology of out-of-hospital SCA in the cities of Barcelona, Girona and Lleida |
| EndTidal CO2 values | Every four minutes during resuscitation maneuvers | To compare EndTidal CO2 values of patients during cardiopulmonary resuscitation (CPR)between boths study arms |
Countries
Spain
Contacts
Primary ContactFrancesc Carmona Jiménez, Doctor
Backup ContactRosa-Maria Lidón, Doctor
Outcome results
None listed