Cardiac ArrestNCT04069377
Mechanical Versus Manual Chest Compression
An observational study of Cardiac Arrest and Cardiopulmonary Resuscitation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators compared mechanical and manual chest compressions in out-of-hospital cardiac arrest cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Cardiopulmonary Resuscitation
- What is being tested?
- LUCAS™ 2 Chest Compression System and Manuel chest compressions by human efforts
- Type of treatment
- Medical device
- How many people
- 214 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2016to 15 Apr 2018
- 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: The data of out-of-hospital cardiac arrest cases undergoing cardiopulmonary resuscitation in the emergency department were analyzed retrospectively.
Who may be able to join
- Over 18 age Cardiac arrest cases Out-of-hospital arrest
Who cannot join
- <18 age
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University, School of Medicine, Department of Emergency Medicine
Ankara, Çankaya, 06800
About this study
Official title: Mechanical Versus Manual Chest Compression: A Retrospective Study in Out-of-hospital Cardiac Arrest
In this study, the investigators compared mechanical and manual chest compressions in out-of-hospital cardiac arrest cases.
Read the detailed description
In this study, the investigators retrospectively analyzed resuscitations performed over a 2-year period and compared manual and mechanical chest compressions in terms of return of spontaneous circulation, 30-day survival, and hospital discharge parameters.
- Conditions
- Cardiac Arrest, Cardiopulmonary Resuscitation
- Being tested
- LUCAS™ 2 Chest Compression System, Manuel chest compressions by human efforts
- Keywords
- Cardiopulmonary Resuscitation, Chest compression, Manuel, Mechanical
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUCAS™ 2 Chest Compression SystemDevice
LUCAS is a portable device designed to rule out the problems encountered during manual chest compression, capable of performing standard and continuous chest compressions at a depth of 4-5 cm and at least 100 times per minute.
Manuel chest compressions by human effortsOther
In this way chest compressions will be handled by humans themselves.
| Study group | Role | What they receive |
|---|---|---|
| Manuel chest compression | Manuel chest compressions will be handled by human efforts. Receives: Other: Manuel chest compressions by human efforts | |
| Mechanical chest compression | In the study, chest compression in the mechanical cardiopulmonary resuscitation group was performed with the Lund University Cardiopulmonary Assist System (LUCAS) Chest Compression System (LUCAS 2). Receives: Device: LUCAS™ 2 Chest Compression System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of the mortality on the 30th day
Mortality from the admission to the 30th day
Measured: 30 days
Rate of the return of spontaneous circulation
Return of spontaneous circulation at least 5 minutes
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Jan 2016
- Primary completion15 Jan 2018
- Study completion15 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Training and Research Hospital
- Responsible party
- Principal investigator, Alp Şener, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069377
- Sponsor's protocol ID
- medybu154
- Status last verified
- Aug 2019
- First submitted
- 23 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) with other researchers.
Publications
Brodal Syversen K, Souvannasacd E, Renger R. Validating the LUCAS(R) mechanical chest compression fit specifications. Am J Emerg Med. 2019 Feb;37(2):371-373. doi: 10.1016/j.ajem.2018.06.069. Epub 2018 Jun 30. No abstract available.
PubMed 30686332Bonnes JL, Brouwer MA, Navarese EP, Verhaert DV, Verheugt FW, Smeets JL, de Boer MJ. Manual Cardiopulmonary Resuscitation Versus CPR Including a Mechanical Chest Compression Device in Out-of-Hospital Cardiac Arrest: A Comprehensive Meta-analysis From Randomized and Observational Studies. Ann Emerg Med. 2016 Mar;67(3):349-360.e3. doi: 10.1016/j.annemergmed.2015.09.023. Epub 2015 Nov 19.
PubMed 26607332Gates S, Quinn T, Deakin CD, Blair L, Couper K, Perkins GD. Mechanical chest compression for out of hospital cardiac arrest: Systematic review and meta-analysis. Resuscitation. 2015 Sep;94:91-7. doi: 10.1016/j.resuscitation.2015.07.002. Epub 2015 Jul 17.
PubMed 26190673
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Versus Manual Chest Compression: A Retrospective Study in Out-of-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT04069377
- Acronym / sponsor ID
- medybu154
- Conditions
- Cardiac Arrest, Cardiopulmonary Resuscitation
- Keywords
- Cardiopulmonary Resuscitation, Chest compression, Manuel, Mechanical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Collaborators
- Ankara Training and Research Hospital
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Apr 2018 (actual)
- First posted
- 28 Aug 2019 (actual)
- 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.
In this study, the investigators compared mechanical and manual chest compressions in out-of-hospital cardiac arrest cases.
Detailed description
In this study, the investigators retrospectively analyzed resuscitations performed over a 2-year period and compared manual and mechanical chest compressions in terms of return of spontaneous circulation, 30-day survival, and hospital discharge parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manuel chest compression | – | Other: Manuel chest compressions by human effortsManuel chest compressions will be handled by human efforts. |
| Mechanical chest compression | – | Device: LUCAS™ 2 Chest Compression SystemIn the study, chest compression in the mechanical cardiopulmonary resuscitation group was performed with the Lund University Cardiopulmonary Assist System (LUCAS) Chest Compression System (LUCAS 2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The data of out-of-hospital cardiac arrest cases undergoing cardiopulmonary resuscitation in the emergency department were analyzed retrospectively.
Key inclusion criteria (1 listed)
- Over 18 age Cardiac arrest cases Out-of-hospital arrest
Key exclusion criteria (1 listed)
- <18 age
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™ 2 Chest Compression SystemLUCAS is a portable device designed to rule out the problems encountered during manual chest compression, capable of performing standard and continuous chest compressions at a depth of 4-5 cm and at least 100 times per minute. | Device | Mechanical chest compression |
| Manuel chest compressions by human effortsIn this way chest compressions will be handled by humans themselves. | Other | Manuel chest compression |
Primary outcome
Rate of the mortality on the 30th day
Time frame: 30 days
Mortality from the admission to the 30th day
Rate of the return of spontaneous circulation
Time frame: 5 minutes
Return of spontaneous circulation at least 5 minutes
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 28 Aug 2019.
- Background: PubMed 30686332Brodal Syversen K, Souvannasacd E, Renger R. Validating the LUCAS(R) mechanical chest compression fit specifications. Am J Emerg Med. 2019 Feb;37(2):371-373. doi: 10.1016/j.ajem.2018.06.069. Epub 2018 Jun 30. No abstract available.
- Background: PubMed 26607332Bonnes JL, Brouwer MA, Navarese EP, Verhaert DV, Verheugt FW, Smeets JL, de Boer MJ. Manual Cardiopulmonary Resuscitation Versus CPR Including a Mechanical Chest Compression Device in Out-of-Hospital Cardiac Arrest: A Comprehensive Meta-analysis From Randomized and Observational Studies. Ann Emerg Med. 2016 Mar;67(3):349-360.e3. doi: 10.1016/j.annemergmed.2015.09.023. Epub 2015 Nov 19.
- Background: PubMed 26190673Gates S, Quinn T, Deakin CD, Blair L, Couper K, Perkins GD. Mechanical chest compression for out of hospital cardiac arrest: Systematic review and meta-analysis. Resuscitation. 2015 Sep;94:91-7. doi: 10.1016/j.resuscitation.2015.07.002. Epub 2015 Jul 17.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Cardiopulmonary Resuscitation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 28 Aug 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 Turkey (Türkiye). 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?
Rate of the mortality on the 30th day (time frame: 30 days). 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?
On the ClinicalTrials.gov record for NCT04069377, which also lists 3 linked publications.
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 28 Aug 2019.