Sudden Cardiac ArrestPhase 3LUCATNCT01521208
LUCAS Chest Compressor Versus Manual Chest Compression in Out-of-hospital Sudden Cardiac Arrest. LUCAT Trial
A Phase 3 study testing LUCAS (Lund University Cardiac Assist Sysrem) and Manual chest compressions in people with Sudden Cardiac Arrest, run by Sistema d'Emergències Mèdiques at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sudden Cardiac Arrest
- What is being tested?
- LUCAS (Lund University Cardiac Assist Sysrem) and Manual chest compressions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2012to Apr 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Rosa-Maria Lidón, Doctor contact
Spain2 sites, 2 recruiting
- Recruiting
Hospital Vall d'Hebron
Barcelona, Barcelona, 08035
Rosa-Maria Lidón, Doctor, rmlidon@vhebron.net
Xavier Nuvials, Doctor, fxnuvials@vhebron.net
- Recruiting
Sistema d'Emergències Mèdiques
L'Hospitalet de Llobregat, Barcelona, 08908
Francesc Carmona Jimenez, Doctor, +34607847717, franciscojosecarmona@gencat.cat
Pilar Palma Padró, Doctor, +34932644400 ext. 11405, pilarpalma@gencat.cat
About this study
Official title: LUcas Continuous Chest Compressions in Out-of-hospital Cardiac Arrest Treatment. The LUCAT Trial
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.
Read the 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).
- Conditions
- Sudden Cardiac Arrest
- Being tested
- LUCAS (Lund University Cardiac Assist Sysrem), Manual chest compressions
- Keywords
- Out-of-Hospital cardiac arrest (OHCA), Chest compressions, LUCAS device
- Medical subject headings
- Death, Sudden, Cardiac, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUCAS (Lund University Cardiac Assist Sysrem)Device
Also called Mechanical continuous chest compressions
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 compressionsOther
Also called Cardiopulmonary resuscitation
Manual CPR according to 2010 ERC guidelines will be performed
| Study group | Role | What they receive |
|---|---|---|
| LUCAS, Continuous chest compressions | Active comparator | Mechanical continuous chest compressions performed by LUCAS device (also during defibrillation) Receives: Device: LUCAS (Lund University Cardiac Assist Sysrem) |
| Manual chest compressions | Active comparator | Manual chest compression is performed, chest compressions halted during defibrillation Receives: Other: Manual chest compressions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 30 days
Secondary outcomes (8)
Restoration of spontaneous circulation
To compare the return of spontaneous circulation (ROSC) between both groups
Measured: 2 hours
EndTidal CO2 values
To compare EndTidal CO2 values of patients during cardiopulmonary resuscitation (CPR)between boths study arms
Measured: Every four minutes during resuscitation maneuvers
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.
Measured: During the first three days and on hospital discharge
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
Measured: 30 days
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
Measured: During the first 24h, at >48h and at 5-7days
Epidemiology of Out-of-Hospital Cardiac Arrest
To describe the epidemiology of out-of-hospital SCA in the cities of Barcelona, Girona and Lleida
Measured: 3 months
To obtain a blood sample for genetic and biological studies
Blood samples from SCA survivors will be kept to perform biological studies.
Measured: 7 days
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
Measured: During the first 24h and during the 24h previous on hospital discharge or at two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sistema d'Emergències Mèdiques
- Sponsor type
- Other government
- Collaborators
- Hospital Vall d'Hebron
- Responsible party
- Principal investigator, Francesc Carmona Jimenez, Sistema d'Emergències Mèdiques
- Investigators
- Pilar Palma Padró, Doctor, Study director, Sistema d'Emergències Mèdiques
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521208
- Sponsor's protocol ID
- SEM-HVH-001
- Acronym
- LUCAT
- Status last verified
- Feb 2012
- First submitted
- 25 Dec 2011
- Last updated
- 6 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUcas Continuous Chest Compressions in Out-of-hospital Cardiac Arrest Treatment. The LUCAT Trial
- ClinicalTrials.gov ID
- NCT01521208
- Acronym / sponsor ID
- LUCAT / SEM-HVH-001
- Conditions
- Sudden Cardiac Arrest
- Keywords
- Out-of-Hospital cardiac arrest (OHCA), Chest compressions, LUCAS device
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sistema d'Emergències MèdiquesOther government
- Collaborators
- Hospital Vall d'Hebron
- Study start
- Jan 2012
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LUCAS, Continuous chest compressions | Active comparator | Device: LUCAS (Lund University Cardiac Assist Sysrem)Mechanical continuous chest compressions performed by LUCAS device (also during defibrillation) |
| Manual chest compressions | Active comparator | Other: Manual chest compressionsManual chest compression is performed, chest compressions halted during defibrillation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUCAS (Lund University Cardiac Assist Sysrem)Also: Mechanical continuous chest compressionsLUCAS device will be placed on patients suffering a cardiac arrest and continuous chest compressions will be performed, even while defibrillation is being applied | Device | LUCAS, Continuous chest compressions |
| Manual chest compressionsAlso: Cardiopulmonary resuscitationManual CPR according to 2010 ERC guidelines will be performed | Other | Manual chest compressions |
Primary outcome
Survival at hospital admittance
Time frame: 2 hours
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)
Time frame: 30 days
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
8 secondary outcomes
Restoration of spontaneous circulation
Time frame: 2 hours
EndTidal CO2 values
Time frame: Every four minutes during resuscitation maneuvers
SOFA scale values
Time frame: During the first three days and on hospital discharge
Days before discharge from Intensive Care Unit (ICU) / Coronary Care Unit (CCU)
Time frame: 30 days
Metabolic (pH, lactate) and inflamatory (leukocytes, C reactive protein) parameters
Time frame: During the first 24h, at >48h and at 5-7days
Epidemiology of Out-of-Hospital Cardiac Arrest
Time frame: 3 months
To obtain a blood sample for genetic and biological studies
Time frame: 7 days
Left ventricular function
Time frame: During the first 24h and during the 24h previous on hospital discharge or at two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa-Maria Lidón, Doctor contact
Pilar Palma Padró, Doctor study director
Sistema d'Emergències Mèdiques
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LUCAS (Lund University Cardiac Assist Sysrem) and Manual chest compressions in people with Sudden Cardiac Arrest, run by Sistema d'Emergències Mèdiques at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesc Carmona Jiménez, Doctor (+34607847717, franciscojosecarmona@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at hospital admittance (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2012.