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

NCT ID: NCT01521208

Last Updated: 2012-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-04-30

Brief Summary

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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

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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).

Conditions

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Sudden Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LUCAS, Continuous chest compressions

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

Group Type ACTIVE_COMPARATOR

LUCAS (Lund University Cardiac Assist Sysrem)

Intervention Type DEVICE

LUCAS device will be placed on patients suffering a cardiac arrest and continuous chest compressions will be performed, even while defibrillation is being applied

Manual chest compressions

Manual chest compression is performed, chest compressions halted during defibrillation

Group Type ACTIVE_COMPARATOR

Manual chest compressions

Intervention Type OTHER

Manual CPR according to 2010 ERC guidelines will be performed

Interventions

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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

Intervention Type DEVICE

Manual chest compressions

Manual CPR according to 2010 ERC guidelines will be performed

Intervention Type OTHER

Other Intervention Names

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Mechanical continuous chest compressions Cardiopulmonary resuscitation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Vall d'Hebron

OTHER

Sponsor Role collaborator

Sistema d'Emergències Mèdiques

OTHER_GOV

Sponsor Role lead

Responsible Party

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Francesc Carmona Jimenez

Assistant Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pilar Palma Padró, Doctor

Role: STUDY_DIRECTOR

Sistema d'Emergències Mèdiques

Locations

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Hospital Vall d'Hebron

Barcelona, Barcelona, Spain

Site Status RECRUITING

Sistema d'Emergències Mèdiques

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Francesc Carmona Jiménez, Doctor

Role: CONTACT

+34607847717

Rosa-Maria Lidón, Doctor

Role: CONTACT

Facility Contacts

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Rosa-Maria Lidón, Doctor

Role: primary

Xavier Nuvials, Doctor

Role: backup

Francesc Carmona Jimenez, Doctor

Role: primary

+34607847717

Pilar Palma Padró, Doctor

Role: backup

+34932644400 ext. 11405

Other Identifiers

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SEM-HVH-001

Identifier Type: -

Identifier Source: org_study_id

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