Cardiac ArrestNCT02479152
The Haemodynamic Effects of Mechanical Standard and Active Chest Compression-decompression During Out-of-hospital CPR
A study testing LUCAS2 AD in people with Cardiac Arrest, run by Physio-Control at 1 site in Norway.
Trial summary
The aim of this randomized out-of-hospital cardiopulmonary resuscitation study is to investigate haemodynamics generated by the standard mechanical external chest compression device (LUCAS™ 2) compared to a new version generating chest compressions and active decompression above the initial starting position of the… 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?
- LUCAS2 AD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2015to Apr 2017
- Phase
- Interventional
- 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
Who may be able to join
- Unexpected adult out-of-hospital non-traumatic cardiac arrest where an attempt of resuscitation is considered appropriate in:
- Patients 18 years or older
Who cannot join
- Traumatic cardiac arrest
- Age believed to be less than 18 years
- Known pregnancy
- Victim not to be resuscitated (DNR orders)
- Internals in prison
- Included once in the study already
- To Small/Large patients
- Sustained ROSC occurring before the LUCAS™ 2 or LUCAS™ 2-AD can be applied to the patient, such that further CPR is not needed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Haemodynamic Effects of Mechanical Standard and Active External Chest Compression-decompression During Out-of-hospital Cardiopulmonary Resuscitation
The aim of this randomized out-of-hospital cardiopulmonary resuscitation study is to investigate haemodynamics generated by the standard mechanical external chest compression device (LUCAS™ 2) compared to a new version generating chest compressions and active decompression above the initial starting position of the suction cup (LUCAS™ 2AD).
Read the detailed description
Based on randomization patients will receive standard or active compression decompression chest compression and the haemodynamic effects will be compared.
- Conditions
- Cardiac Arrest
- Being tested
- LUCAS2 AD
- Keywords
- Mechanical CPR, Hemodynamics
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUCAS2 ADDevice
LUCAS™ 2AD with compressions like the standard LUCAS™ 2 but added decompressions above the initial start position.
| Study group | Role | What they receive |
|---|---|---|
| LUCAS 2 AD | Active comparator | LUCAS 2 AD will be used for CPR Receives: Device: LUCAS2 AD |
| LUCAS2 | Other | LUCAS2 will be used for CPR Receives: Device: LUCAS2 AD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamics measured as EtCO2
Measured: During 30 minutes of CPR
Secondary outcomes (4)
Intra arterial blood pressures,
Measured: During 30 minutes of CPR
Oximetry,
Measured: During 30 minutes of CPR
ROSC (Return of spontaneous circulation)
Measured: During CPR
safety
Measured: During 30 minutes of CPR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Physio-Control
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GE Healthcare
- Responsible party
- Principal investigator, Lars Wik, Ullevaal University Hospital
- Investigators
- Lars Wik, MD, PhD, Principal investigator, Oslo Universitetssykehus. Ullevål, Norway.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479152
- Sponsor's protocol ID
- Protocol ID 11, March 2015
- Status last verified
- Aug 2017
- First submitted
- 13 Apr 2015
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berve PO, Hardig BM, Skalhegg T, Kongsgaard H, Kramer-Johansen J, Wik L. Mechanical active compression-decompression versus standard mechanical cardiopulmonary resuscitation: A randomised haemodynamic out-of-hospital cardiac arrest study. Resuscitation. 2022 Jan;170:1-10. doi: 10.1016/j.resuscitation.2021.10.026. Epub 2021 Oct 25.
PubMed 34710550
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Haemodynamic Effects of Mechanical Standard and Active External Chest Compression-decompression During Out-of-hospital Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT02479152
- Acronym / sponsor ID
- Protocol ID 11, March 2015
- Conditions
- Cardiac Arrest
- Keywords
- Mechanical CPR, Hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Physio-ControlIndustry (pharma, biotech, devices)
- Collaborators
- GE Healthcare
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 24 Jun 2015 (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 aim of this randomized out-of-hospital cardiopulmonary resuscitation study is to investigate haemodynamics generated by the standard mechanical external chest compression device (LUCAS™ 2) compared to a new version generating chest compressions and active decompression above the initial starting position of the suction cup (LUCAS™ 2AD).
Detailed description
Based on randomization patients will receive standard or active compression decompression chest compression and the haemodynamic effects will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LUCAS 2 AD | Active comparator | Device: LUCAS2 ADLUCAS 2 AD will be used for CPR |
| LUCAS2 | Other | Device: LUCAS2 ADLUCAS2 will be used for CPR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unexpected adult out-of-hospital non-traumatic cardiac arrest where an attempt of resuscitation is considered appropriate in:
- Patients 18 years or older
Key exclusion criteria (8 listed)
- Traumatic cardiac arrest
- Age believed to be less than 18 years
- Known pregnancy
- Victim not to be resuscitated (DNR orders)
- Internals in prison
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 |
|---|---|---|
| LUCAS2 ADLUCAS™ 2AD with compressions like the standard LUCAS™ 2 but added decompressions above the initial start position. | Device | LUCAS 2 AD, LUCAS2 |
Primary outcome
Hemodynamics measured as EtCO2
Time frame: During 30 minutes of CPR
4 secondary outcomes
Intra arterial blood pressures,
Time frame: During 30 minutes of CPR
Oximetry,
Time frame: During 30 minutes of CPR
ROSC (Return of spontaneous circulation)
Time frame: During CPR
safety
Time frame: During 30 minutes of 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 4 Aug 2017.
- Derived from this study: PubMed 34710550Berve PO, Hardig BM, Skalhegg T, Kongsgaard H, Kramer-Johansen J, Wik L. Mechanical active compression-decompression versus standard mechanical cardiopulmonary resuscitation: A randomised haemodynamic out-of-hospital cardiac arrest study. Resuscitation. 2022 Jan;170:1-10. doi: 10.1016/j.resuscitation.2021.10.026. Epub 2021 Oct 25.
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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.
Lars Wik, MD, PhD principal investigator
Oslo Universitetssykehus. Ullevål, Norway.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LUCAS2 AD in people with Cardiac Arrest, run by Physio-Control at 1 site in Norway.
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 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: finished, as of the sponsor's last update on 4 Aug 2017. 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 Norway. 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?
Hemodynamics measured as EtCO2 (time frame: During 30 minutes of CPR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02479152, which also lists 1 linked publication.
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 4 Aug 2017.