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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Sistema d’Emergències Mèdiques.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hospital Vall d'Hebron
Information provided by (Responsible Party):
Francesc Carmona Jimenez, Sistema d'Emergències Mèdiques
ClinicalTrials.gov Identifier:
NCT01521208
First received: December 25, 2011
Last updated: February 3, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Sudden Cardiac Arrest
Device: LUCAS (Lund University Cardiac Assist Sysrem)
Other: Manual chest compressions
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: LUcas Continuous Chest Compressions in Out-of-hospital Cardiac Arrest Treatment. The LUCAT Trial

Resource links provided by NLM:


Further study details as provided by Sistema d’Emergències Mèdiques:

Primary Outcome Measures:
  • Survival at hospital admittance [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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

  • Survival on discharge from hospital (or 30 days if not applicable) in acceptable neurological state (CPC scale 1 or 2) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Restoration of spontaneous circulation [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    To compare the return of spontaneous circulation (ROSC) between both groups

  • EndTidal CO2 values [ Time Frame: Every four minutes during resuscitation maneuvers ] [ Designated as safety issue: No ]
    To compare EndTidal CO2 values of patients during cardiopulmonary resuscitation (CPR)between boths study arms

  • SOFA scale values [ Time Frame: During the first three days and on hospital discharge ] [ Designated as safety issue: No ]
    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.

  • Days before discharge from Intensive Care Unit (ICU) / Coronary Care Unit (CCU) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: During the first 24h, at >48h and at 5-7days ] [ Designated as safety issue: No ]
    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

  • Epidemiology of Out-of-Hospital Cardiac Arrest [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To describe the epidemiology of out-of-hospital SCA in the cities of Barcelona, Girona and Lleida

  • To obtain a blood sample for genetic and biological studies [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Blood samples from SCA survivors will be kept to perform biological studies.

  • Left ventricular function [ Time Frame: During the first 24h and during the 24h previous on hospital discharge or at two months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 400
Study Start Date: January 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Cardiopulmonary resuscitation

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521208

Contacts
Contact: Francesc Carmona Jiménez, Doctor +34607847717 franciscojosecarmona@gencat.cat
Contact: Rosa-Maria Lidón, Doctor rmlidon@vhebron.net

Locations
Spain
Sistema d'Emergències Mèdiques Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08908
Contact: Francesc Carmona Jimenez, Doctor    +34607847717    franciscojosecarmona@gencat.cat   
Contact: Pilar Palma Padró, Doctor    +34932644400 ext 11405    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         
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Rosa-Maria Lidón, Doctor       rmlidon@vhebron.net   
Contact: Xavier Nuvials, Doctor       fxnuvials@vhebron.net   
Principal Investigator: Rosa-Maria Lidón, Doctor         
Principal Investigator: Xavier Nuvials, Doctor         
Sub-Investigator: Jordi Bañeras, Doctor         
Sponsors and Collaborators
Sistema d’Emergències Mèdiques
Hospital Vall d'Hebron
Investigators
Study Director: Pilar Palma Padró, Doctor Sistema d’Emergències Mèdiques
  More Information

No publications provided

Responsible Party: Francesc Carmona Jimenez, Assistant Investigator, Sistema d'Emergències Mèdiques
ClinicalTrials.gov Identifier: NCT01521208     History of Changes
Other Study ID Numbers: SEM-HVH-001
Study First Received: December 25, 2011
Last Updated: February 3, 2012
Health Authority: Spain: Departament de Salut de la Generalitat de Catalunya

Keywords provided by Sistema d’Emergències Mèdiques:
Out-of-Hospital cardiac arrest (OHCA)
Chest compressions
LUCAS device

Additional relevant MeSH terms:
Heart Arrest
Death, Sudden, Cardiac
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Death
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014