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

Sistema d'Emergències Mèdiques

Status and phase: Unknown; Phase 3

Conditions: Sudden Cardiac Arrest

Treatments: Other: Manual chest compressions; Device: LUCAS (Lund University Cardiac Assist Sysrem)

Study type: Interventional

Funder types: Other

Identifiers

NCT01521208

SEM-HVH-001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

LUCAS, Continuous chest compressions

Active Comparator group

Description:

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

Treatment:

Device: LUCAS (Lund University Cardiac Assist Sysrem)

Manual chest compressions

Active Comparator group

Description:

Manual chest compression is performed, chest compressions halted during defibrillation

Treatment:

Other: Manual chest compressions