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

Sudden Cardiac Arrest Clinical Trial

— LUCAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01521208
• Other study ID #: SEM-HVH-001
• Status: Recruiting
• Phase: Phase 3
• First received: December 25, 2011
• Last updated: February 3, 2012
• Start date: January 2012
• Est. completion date: April 2014

Study information

• Verified date: February 2012
• Source: Sistema d’Emergències Mèdiques
• Contact: Francesc Carmona Jiménez, Doctor
• Phone: +34607847717
• Email: franciscojosecarmona[@]gencat.cat
• Is FDA regulated: No
• Health authority: Spain: Departament de Salut de la Generalitat de Catalunya
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Heart Arrest
• Out-of-Hospital Cardiac Arrest
• Sudden Cardiac Arrest

Intervention

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:
• Manual chest compressions
Manual CPR according to 2010 ERC guidelines will be performed

Locations

Country	Name	City	State
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Sistema d'Emergències Mèdiques	Hospitalet de Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Sistema d’Emergències Mèdiques	Hospital Vall d'Hebron

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Restoration of spontaneous circulation	To compare the return of spontaneous circulation (ROSC) between both groups	2 hours	No
Secondary	EndTidal CO2 values	To compare EndTidal CO2 values of patients during cardiopulmonary resuscitation (CPR)between boths study arms	Every four minutes during resuscitation maneuvers	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	To obtain a blood sample for genetic and biological studies	Blood samples from SCA survivors will be kept to perform biological studies.	7 days	No
Secondary	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	No