LUCAS Chest Compressor Versus Manual Chest Compression in Out-of-hospital Sudden Cardiac Arrest. LUCAT Trial
- Conditions
- Sudden Cardiac Arrest
- Interventions
- Other: Manual chest compressionsDevice: LUCAS (Lund University Cardiac Assist Sysrem)
- Registration Number
- NCT01521208
- Lead Sponsor
- Sistema d'Emergències Mèdiques
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Manual chest compressions Manual chest compressions Manual chest compression is performed, chest compressions halted during defibrillation LUCAS, Continuous chest compressions LUCAS (Lund University Cardiac Assist Sysrem) Mechanical continuous chest compressions performed by LUCAS device (also during defibrillation)
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method Restoration of spontaneous circulation 2 hours To compare the return of spontaneous circulation (ROSC) between both groups
EndTidal CO2 values Every four minutes during resuscitation maneuvers To compare EndTidal CO2 values of patients during cardiopulmonary resuscitation (CPR)between boths study arms
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
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.
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
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
To obtain a blood sample for genetic and biological studies 7 days Blood samples from SCA survivors will be kept to perform biological studies.
Trial Locations
- Locations (2)
Sistema d'Emergències Mèdiques
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain