Cardiac ArrestNCT01745926
Implementation of LUCAS 2 in Helicopter Rescue in South Tyrol
An observational study of Cardiac Arrest, run by Institute of Mountain Emergency Medicine at 1 site in Italy.
Trial summary
Cardiopulmonary resuscitation (CPR) is used to maintain adequate perfusion of vital organs in cardiac arrest patients and is fundamental for the neurological outcome and survival of these individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- MECHANICAL CHEST COMPRESSION
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2013to Mar 2016
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in cardiac arrest from all causes requiring CPR
Who may be able to join
- cardiac arrest with indication of CPR
- informed consent for those regaining legal competence
Who cannot join
- declaration of death on site
- contraindications of using the device
- age <18 y
Trial locations and contacts
1 site in 1 country.
About this study
Cardiopulmonary resuscitation (CPR) is used to maintain adequate perfusion of vital organs in cardiac arrest patients and is fundamental for the neurological outcome and survival of these individuals. Unfortunately, the quality of CPR may be inadequate due largely to ineffective chest compressions resulting from rescuer fatigue and interruptions in compressions. The LUCAS device (Lund University Cardiopulmonary Assist System, Jolife, Lund, Sweden), introduced in 2002, is the most extensively tested and applied automated alternative to manual CPR for in-hospital care of cardiac arrest patients and during ambulance transfer; the feasibility of application of this device in helicopter emergency medical service (HEMS) operations, however, has never been addressed. The objective of this project is to equip the three active rescue helicopters in South Tyrol with the LUCAS 2 mechanical chest compression device to answer the question: What is the feasibility and efficiency of using this device for prolonged CPR in cardiac arrest patients requiring CPR during HEMS rescue operations and transport?
Read the detailed description
This is a non-controlled, observational study. Physiological endpoints: MAP (mean arterial pressure); etCO2 (end-tidal expiratory pCO2); ROSC (return of spontaneous circulation); PaO2 (arterial pO2); PaCO2 (arterial pCO2); endpoints to assess feasibility: time from arrival to start of mechanical compressions, problems during transfer into the helicopter and in-field manoeuvers, problems with application of device, problems with patient transfer to hospital premises, hands-off time, personnel requirements.
- Conditions
- Cardiac Arrest
- Being tested
- MECHANICAL CHEST COMPRESSION
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MECHANICAL CHEST COMPRESSIONDevice
Also called LUCAS2
| Study group | Role | What they receive |
|---|---|---|
| CPR | MECHANICAL CHEST COMPRESSION Receives: Device: MECHANICAL CHEST COMPRESSION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from arrival of rescue team to start of mechanical compressions
Measured: assessed immediatly after the operation is concluded
Presence of abdominal or thoracic lesions caused by automated chest compressor
Measured: Assessed at clinical examination during hospital stay (day 1 to day 30) or autopsy
Secondary outcomes (5)
Mean arterial pressure
Measured: At hospital arrival (expected between 5 minutes and 1 hour from start CPR)
End-tidal expiratory pCO2
Measured: At hospital arrival (expected between 5 minutes and 1 hour from start CPR)
Return of spontaneous circulation
Measured: Could be each moment during CPR
Arterial pO2
Measured: At hospital arrival (expected between 5 minutes and 1 hour from start CPR)
Arterial pCO2
Measured: At hospital arrival (expected between 5 minutes and 1 hour from start CPR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startApr 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Institute of Mountain Emergency Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hermann Brugger, Prof, Study director, Institute of Mountain Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745926
- Sponsor's protocol ID
- V/15/11
- Status last verified
- Jul 2019
- First submitted
- 5 Dec 2012
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of LUCAS 2 in Helicopter Rescue in South Tyrol
- ClinicalTrials.gov ID
- NCT01745926
- Acronym / sponsor ID
- V/15/11
- Conditions
- Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Institute of Mountain Emergency MedicineUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Dec 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.
Cardiopulmonary resuscitation (CPR) is used to maintain adequate perfusion of vital organs in cardiac arrest patients and is fundamental for the neurological outcome and survival of these individuals. Unfortunately, the quality of CPR may be inadequate due largely to ineffective chest compressions resulting from rescuer fatigue and interruptions in compressions. The LUCAS device (Lund University Cardiopulmonary Assist System, Jolife, Lund, Sweden), introduced in 2002, is the most extensively tested and applied automated alternative to manual CPR for in-hospital care of cardiac arrest patients and during ambulance transfer; the feasibility of application of this device in helicopter emergency medical service (HEMS) operations, however, has never been addressed. The objective of this project is to equip the three active rescue helicopters in South Tyrol with the LUCAS 2 mechanical chest compression device to answer the question: What is the feasibility and efficiency of using this device for prolonged CPR in cardiac arrest patients requiring CPR during HEMS rescue operations and transport?
Detailed description
This is a non-controlled, observational study. Physiological endpoints: MAP (mean arterial pressure); etCO2 (end-tidal expiratory pCO2); ROSC (return of spontaneous circulation); PaO2 (arterial pO2); PaCO2 (arterial pCO2); endpoints to assess feasibility: time from arrival to start of mechanical compressions, problems during transfer into the helicopter and in-field manoeuvers, problems with application of device, problems with patient transfer to hospital premises, hands-off time, personnel requirements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPR | – | Device: MECHANICAL CHEST COMPRESSIONMECHANICAL CHEST COMPRESSION |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in cardiac arrest from all causes requiring CPR
Key inclusion criteria (2 listed)
- cardiac arrest with indication of CPR
- informed consent for those regaining legal competence
Key exclusion criteria (3 listed)
- declaration of death on site
- contraindications of using the device
- age <18 y
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 |
|---|---|---|
| MECHANICAL CHEST COMPRESSIONAlso: LUCAS2 | Device | CPR |
Primary outcome
Time from arrival of rescue team to start of mechanical compressions
Time frame: assessed immediatly after the operation is concluded
Presence of abdominal or thoracic lesions caused by automated chest compressor
Time frame: Assessed at clinical examination during hospital stay (day 1 to day 30) or autopsy
5 secondary outcomes
Mean arterial pressure
Time frame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR)
End-tidal expiratory pCO2
Time frame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR)
Return of spontaneous circulation
Time frame: Could be each moment during CPR
Arterial pO2
Time frame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR)
Arterial pCO2
Time frame: At hospital arrival (expected between 5 minutes and 1 hour from start CPR)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
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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.
Hermann Brugger, Prof study director
Institute of Mountain Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Institute of Mountain Emergency Medicine at 1 site in Italy.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from arrival of rescue team to start of mechanical compressions (time frame: assessed immediatly after the operation is concluded). 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 24 Jul 2019.