NCT01521208

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2011

Completed
7 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

February 6, 2012

Status Verified

February 1, 2012

Enrollment Period

2.1 years

First QC Date

December 25, 2011

Last Update Submit

February 3, 2012

Conditions

Sudden Cardiac Arrest

Keywords

Out-of-Hospital cardiac arrest (OHCA)Chest compressionsLUCAS device

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Restoration of spontaneous circulation

    2 hours

  • EndTidal CO2 values

    Every four minutes during resuscitation maneuvers

  • SOFA scale values

    During the first three days and on hospital discharge

  • Days before discharge from Intensive Care Unit (ICU) / Coronary Care Unit (CCU)

    30 days

  • Metabolic (pH, lactate) and inflamatory (leukocytes, C reactive protein) parameters

    During the first 24h, at >48h and at 5-7days

  • +3 more secondary outcomes

Study Arms (2)

LUCAS, Continuous chest compressions

ACTIVE COMPARATOR

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

Device: LUCAS (Lund University Cardiac Assist Sysrem)

Manual chest compressions

ACTIVE COMPARATOR

Manual chest compression is performed, chest compressions halted during defibrillation

Other: Manual chest compressions

Interventions

LUCAS (Lund University Cardiac Assist Sysrem)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

Also known as: Mechanical continuous chest compressions
LUCAS, Continuous chest compressions
Manual chest compressionsOTHER

Manual CPR according to 2010 ERC guidelines will be performed

Also known as: Cardiopulmonary resuscitation
Manual chest compressions

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

Sistema d'Emergències Mèdiques

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

MeSH Terms

Conditions

Death, Sudden, CardiacOut-of-Hospital Cardiac Arrest

Interventions

Cardiopulmonary Resuscitation

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ResuscitationEmergency TreatmentTherapeutics

Study Officials

  • Pilar Palma Padró, Doctor

    Sistema d'Emergències Mèdiques

    STUDY DIRECTOR

Central Study Contacts

Francesc Carmona Jiménez, Doctor

CONTACT

+34607847717franciscojosecarmona@gencat.cat

Rosa-Maria Lidón, Doctor

CONTACT

rmlidon@vhebron.net

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Investigator

Study Record Dates

First Submitted

December 25, 2011

First Posted

January 30, 2012

Study Start

January 1, 2012

Primary Completion

February 1, 2014

Study Completion

April 1, 2014

Last Updated

February 6, 2012

Record last verified: 2012-02

Locations

ES(2)