Clinical trial NCT01521208: LUCAS Chest Compressor Versus Manual Chest Compression in Out-of-hospital Sudden Cardiac Arrest. LUCAT Trial
Official title: LUcas Continuous Chest Compressions in Out-of-hospital Cardiac Arrest Treatment. The LUCAT Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sudden Cardiac Arrest
Keywords: Out-of-Hospital cardiac arrest (OHCA)
Chest compressions
LUCAS device
Lead sponsor: Sistema d'Emergències Mèdiques
Sponsor class: OTHER_GOV
Collaborators: name: Hospital Vall d'Hebron
First posted: 2012-01-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Survival at hospital admittance
timeFrame: 2 hours
measure: Survival on discharge from hospital (or 30 days if not applicable) in acceptable neurological state (CPC scale 1 or 2)
timeFrame: 30 days
Secondary outcomes:
measure: Restoration of spontaneous circulation
timeFrame: 2 hours
measure: EndTidal CO2 values
timeFrame: Every four minutes during resuscitation maneuvers
measure: SOFA scale values
timeFrame: During the first three days and on hospital discharge
measure: Days before discharge from Intensive Care Unit (ICU) / Coronary Care Unit (CCU)
timeFrame: 30 days
measure: Metabolic (pH, lactate) and inflamatory (leukocytes, C reactive protein) parameters
timeFrame: During the first 24h, at >48h and at 5-7days
measure: Epidemiology of Out-of-Hospital Cardiac Arrest
timeFrame: 3 months
measure: To obtain a blood sample for genetic and biological studies
timeFrame: 7 days
measure: Left ventricular function
timeFrame: During the first 24h and during the 24h previous on hospital discharge or at two months
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Sistema d'Emergències Mèdiques
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
affiliation: Sistema d'Emergències Mèdiques
name: Pilar Palma Padró, Doctor
role: STUDY_DIRECTOR
References: