LUCAS Chest Compressor Versus Manual Chest Compression in Out-of-hospital Sudden Cardiac Arrest. LUCAT Trial (LUCAT)

LUcas Continuous Chest Compressions in Out-of-hospital Cardiac Arrest Treatment. The LUCAT Trial

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.

Study Overview

• Status: Unknown
• Conditions: Sudden Cardiac Arrest
• Intervention / Treatment: Device: LUCAS (Lund University Cardiac Assist Sysrem); Other: Manual chest compressions

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).

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Francesc Carmona Jimenez, Doctor; Phone Number: +34607847717; Email: franciscojosecarmona@gencat.cat
• Study Contact Backup: Name: Rosa-Maria Lidón, Doctor; Email: rmlidon@vhebron.net

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Vall d'Hebron
    • Contact: Rosa-Maria Lidón, Doctor; Email: rmlidon@vhebron.net
    • Contact: Xavier Nuvials, Doctor; Email: fxnuvials@vhebron.net
    • Principal Investigator: Rosa-Maria Lidón, Doctor
    • Principal Investigator: Xavier Nuvials, Doctor
    • Sub-Investigator: Jordi Bañeras, Doctor
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08908
      • Recruiting
      • Sistema d'Emergències Mèdiques
      • Contact: Francesc Carmona Jimenez, Doctor; Phone Number: +34607847717; Email: franciscojosecarmona@gencat.cat
      • Contact: Pilar Palma Padró, Doctor; Phone Number: 11405 +34932644400; Email: pilarpalma@gencat.cat
      • Principal Investigator: Francesc Carmona Jiménez, Doctor
      • Sub-Investigator: Rafael Bethencourt Guimerà, Doctor
      • Sub-Investigator: Rebeca Cadenas Martín, Doctor
      • Sub-Investigator: Hisao Onaga Pueyo, Doctor
      • Sub-Investigator: Antonio Llubés Mas, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LUCAS, Continuous chest compressions; Mechanical continuous chest compressions performed by LUCAS device (also during defibrillation)	Device: LUCAS (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; Other Names: Mechanical continuous chest compressions
Active Comparator: Manual chest compressions; Manual chest compression is performed, chest compressions halted during defibrillation	Other: Manual chest compressions; Manual CPR according to 2010 ERC guidelines will be performed; Other Names: Cardiopulmonary resuscitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Sistema d'Emergències Mèdiques
• Collaborators: Hospital Vall d'Hebron
• Investigators: Study Director: Pilar Palma Padró, Doctor, Sistema d'Emergències Mèdiques

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): February 1, 2014
• Study Completion (Anticipated): April 1, 2014

Study Registration Dates

• First Submitted: December 25, 2011
• First Submitted That Met QC Criteria: January 27, 2012
• First Posted (Estimate): January 30, 2012

Study Record Updates

• Last Update Posted (Estimate): February 6, 2012
• Last Update Submitted That Met QC Criteria: February 3, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Chest compressions; Out-of-Hospital cardiac arrest (OHCA); LUCAS device
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Heart Arrest; Out-of-Hospital Cardiac Arrest; Death, Sudden, Cardiac
• Other Study ID Numbers: SEM-HVH-001