LUcas Continuous Chest Compressions in Out-of-hospital Cardiac Arrest Treatment. The LUCAT Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Sudden Cardiac Arrest
- Sponsor
- Sistema d'Emergències Mèdiques
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Survival on discharge from hospital (or 30 days if not applicable) in acceptable neurological state (CPC scale 1 or 2)
- Last Updated
- 14 years ago
Overview
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).
Investigators
Francesc Carmona Jimenez
Assistant Investigator
Sistema d'Emergències Mèdiques
Eligibility Criteria
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
Outcomes
Primary Outcomes
Survival on discharge from hospital (or 30 days if not applicable) in acceptable neurological state (CPC scale 1 or 2)
Time Frame: 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
Time Frame: 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 Outcomes
- Restoration of spontaneous circulation(2 hours)
- EndTidal CO2 values(Every four minutes during resuscitation maneuvers)
- Left ventricular function(During the first 24h and during the 24h previous on hospital discharge or at two months)
- SOFA scale values(During the first three days and on hospital discharge)
- Epidemiology of Out-of-Hospital Cardiac Arrest(3 months)
- Days before discharge from Intensive Care Unit (ICU) / Coronary Care Unit (CCU)(30 days)
- Metabolic (pH, lactate) and inflamatory (leukocytes, C reactive protein) parameters(During the first 24h, at >48h and at 5-7days)
- To obtain a blood sample for genetic and biological studies(7 days)