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

Primary Purpose

Sudden Cardiac Arrest

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
LUCAS (Lund University Cardiac Assist Sysrem)
Manual chest compressions
Sponsored by
Sistema d'Emergències Mèdiques
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sudden Cardiac Arrest focused on measuring Out-of-Hospital cardiac arrest (OHCA), Chest compressions, LUCAS device

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sistema d'Emergències MèdiquesRecruiting
  • Hospital Vall d'HebronRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

LUCAS, Continuous chest compressions

Manual chest compressions

Arm Description

Mechanical continuous chest compressions performed by LUCAS device (also during defibrillation)

Manual chest compression is performed, chest compressions halted during defibrillation

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Restoration of spontaneous circulation
To compare the return of spontaneous circulation (ROSC) between both groups
EndTidal CO2 values
To compare EndTidal CO2 values of patients during cardiopulmonary resuscitation (CPR)between boths study arms
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.
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
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
Epidemiology of Out-of-Hospital Cardiac Arrest
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
Blood samples from SCA survivors will be kept to perform biological studies.
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

Full Information

First Posted
December 25, 2011
Last Updated
February 3, 2012
Sponsor
Sistema d'Emergències Mèdiques
Collaborators
Hospital Vall d'Hebron
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1. Study Identification

Unique Protocol Identification Number
NCT01521208
Brief Title
LUCAS Chest Compressor Versus Manual Chest Compression in Out-of-hospital Sudden Cardiac Arrest. LUCAT Trial
Acronym
LUCAT
Official Title
LUcas Continuous Chest Compressions in Out-of-hospital Cardiac Arrest Treatment. The LUCAT Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sistema d'Emergències Mèdiques
Collaborators
Hospital Vall d'Hebron

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Cardiac Arrest
Keywords
Out-of-Hospital cardiac arrest (OHCA), Chest compressions, LUCAS device

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LUCAS, Continuous chest compressions
Arm Type
Active Comparator
Arm Description
Mechanical continuous chest compressions performed by LUCAS device (also during defibrillation)
Arm Title
Manual chest compressions
Arm Type
Active Comparator
Arm Description
Manual chest compression is performed, chest compressions halted during defibrillation
Intervention Type
Device
Intervention Name(s)
LUCAS (Lund University Cardiac Assist Sysrem)
Other Intervention Name(s)
Mechanical continuous chest compressions
Intervention Description
LUCAS device will be placed on patients suffering a cardiac arrest and continuous chest compressions will be performed, even while defibrillation is being applied
Intervention Type
Other
Intervention Name(s)
Manual chest compressions
Other Intervention Name(s)
Cardiopulmonary resuscitation
Intervention Description
Manual CPR according to 2010 ERC guidelines will be performed
Primary Outcome Measure Information:
Title
Survival at hospital admittance
Description
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
Time Frame
2 hours
Title
Survival on discharge from hospital (or 30 days if not applicable) in acceptable neurological state (CPC scale 1 or 2)
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Restoration of spontaneous circulation
Description
To compare the return of spontaneous circulation (ROSC) between both groups
Time Frame
2 hours
Title
EndTidal CO2 values
Description
To compare EndTidal CO2 values of patients during cardiopulmonary resuscitation (CPR)between boths study arms
Time Frame
Every four minutes during resuscitation maneuvers
Title
SOFA scale values
Description
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.
Time Frame
During the first three days and on hospital discharge
Title
Days before discharge from Intensive Care Unit (ICU) / Coronary Care Unit (CCU)
Description
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
Time Frame
30 days
Title
Metabolic (pH, lactate) and inflamatory (leukocytes, C reactive protein) parameters
Description
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
Time Frame
During the first 24h, at >48h and at 5-7days
Title
Epidemiology of Out-of-Hospital Cardiac Arrest
Description
To describe the epidemiology of out-of-hospital SCA in the cities of Barcelona, Girona and Lleida
Time Frame
3 months
Title
To obtain a blood sample for genetic and biological studies
Description
Blood samples from SCA survivors will be kept to perform biological studies.
Time Frame
7 days
Title
Left ventricular function
Description
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
Time Frame
During the first 24h and during the 24h previous on hospital discharge or at two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesc Carmona Jiménez, Doctor
Phone
+34607847717
Email
franciscojosecarmona@gencat.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Rosa-Maria Lidón, Doctor
Email
rmlidon@vhebron.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pilar Palma Padró, Doctor
Organizational Affiliation
Sistema d'Emergències Mèdiques
Official's Role
Study Director
Facility Information:
Facility Name
Sistema d'Emergències Mèdiques
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesc Carmona Jimenez, Doctor
Phone
+34607847717
Email
franciscojosecarmona@gencat.cat
First Name & Middle Initial & Last Name & Degree
Pilar Palma Padró, Doctor
Phone
+34932644400
Ext
11405
Email
pilarpalma@gencat.cat
First Name & Middle Initial & Last Name & Degree
Francesc Carmona Jiménez, Doctor
First Name & Middle Initial & Last Name & Degree
Rafael Bethencourt Guimerà, Doctor
First Name & Middle Initial & Last Name & Degree
Rebeca Cadenas Martín, Doctor
First Name & Middle Initial & Last Name & Degree
Hisao Onaga Pueyo, Doctor
First Name & Middle Initial & Last Name & Degree
Antonio Llubés Mas, Doctor
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa-Maria Lidón, Doctor
Email
rmlidon@vhebron.net
First Name & Middle Initial & Last Name & Degree
Xavier Nuvials, Doctor
Email
fxnuvials@vhebron.net
First Name & Middle Initial & Last Name & Degree
Rosa-Maria Lidón, Doctor
First Name & Middle Initial & Last Name & Degree
Xavier Nuvials, Doctor
First Name & Middle Initial & Last Name & Degree
Jordi Bañeras, Doctor

12. IPD Sharing Statement

Learn more about this trial

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

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