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| Name | Class |
|---|---|
| Hospital Vall d'Hebron | OTHER |
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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.
The primary goals of the trial are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LUCAS, Continuous chest compressions | Active Comparator | Mechanical continuous chest compressions performed by LUCAS device (also during defibrillation) |
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| Manual chest compressions | Active Comparator | Manual chest compression is performed, chest compressions halted during defibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LUCAS (Lund University Cardiac Assist Sysrem) | Device | LUCAS device will be placed on patients suffering a cardiac arrest and continuous chest compressions will be performed, even while defibrillation is being applied |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesc Carmona Jiménez, Doctor | Contact | +34607847717 | franciscojosecarmona@gencat.cat | |
| Rosa-Maria Lidón, Doctor | Contact | rmlidon@vhebron.net |
| Name | Affiliation | Role |
|---|---|---|
| Pilar Palma Padró, Doctor | Sistema d'Emergències Mèdiques | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Vall d'Hebron | Recruiting | Barcelona | Barcelona | 08035 | Spain |
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| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
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| ID | Term |
|---|---|
| D016887 | Cardiopulmonary Resuscitation |
| ID | Term |
|---|---|
| D012151 | Resuscitation |
| D004638 | Emergency Treatment |
| D013812 | Therapeutics |
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| Manual chest compressions | Other | Manual CPR according to 2010 ERC guidelines will be performed |
|
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| 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 |
| Sistema d'Emergències Mèdiques | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
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| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |