Cardiac ArrestNCT04422938
Mechanical Versus Manual Cardiopulmonary Resuscitation
An observational study of Cardiac Arrest and 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 in-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, Resuscitation
- What is being tested?
- Manuel chest compressions handled by clinicians and LUCAS™ 2 Chest Compression System
- Type of treatment
- Medical device
- How many people
- 303 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2016to 31 Mar 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: Cases with cardiac arrest in-hospital environment (in emergency department) and whose had manual or mechanical cardiopulmonary resuscitation in emergency department included in the study; data were collected hospital management information system and analyzed retropectively.
Who may be able to join
- Over 18 age Cardiac arrest cases In-hospital cardiac arrest cases Resuscitations performed in emergency department
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 In-hospital Cardiac Arrest
In this study, the investigators compared mechanical and manual chest compressions in in-hospital cardiac arrest cases.
Read the detailed description
In this study, the investigators analyzed cardiopulmonary resuscitations performed over a 2-year period in an emergency department of a training and research hospital and compared success of manual and mechanical chest compressions in terms of return of spontaneous circulation, 30-day survival, and hospital discharge. Investigators present the study as an in-hospital cardiac arrest study; however, all of the resuscitation performed in the cases included in the study were performed in the emergency department.
- Conditions
- Cardiac Arrest, Resuscitation
- Being tested
- Manuel chest compressions handled by clinicians, LUCAS™ 2 Chest Compression System
- Keywords
- Cardiopulmonary Resuscitation, Chest compression, In-hospital, Mechanical, Manuel
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manuel chest compressions handled by cliniciansOther
Compressions will be handled by human efforts
LUCAS™ 2 Chest Compression SystemDevice
LUCAS-2 model piston-based mechanical chest compression device was used for mechanical chest compressions
| Study group | Role | What they receive |
|---|---|---|
| Manuel compression | Manuel chest compressions will be handled by clinicians Receives: Other: Manuel chest compressions handled by clinicians | |
| Mechanical compression | Mechanical chest compressions will be handled via mechanical chest compression device Receives: Device: LUCAS™ 2 Chest Compression System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate on the 30th day
Mortality rates from the hospital admission to the 30th day
Measured: 30 days
Rate of the return of spontaneous circulation
Rate of return of the spontaneous circulation with duration at least five 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 posted9 Jun 2020
- Study start1 Jan 2016
- Primary completion31 Dec 2017
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- 303 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
- NCT04422938
- Sponsor's protocol ID
- medybu-IN
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 9 Jun 2020
- 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
Couper K, Yeung J, Nicholson T, Quinn T, Lall R, Perkins GD. Mechanical chest compression devices at in-hospital cardiac arrest: A systematic review and meta-analysis. Resuscitation. 2016 Jun;103:24-31. doi: 10.1016/j.resuscitation.2016.03.004. Epub 2016 Mar 11.
PubMed 26976675Couper K, Quinn T, Lall R, Devrell A, Orriss B, Seers K, Yeung J, Perkins GD; COMPRESS-RCT collaborators. Mechanical versus manual chest compressions in the treatment of in-hospital cardiac arrest patients in a non-shockable rhythm: a randomised controlled feasibility trial (COMPRESS-RCT). Scand J Trauma Resusc Emerg Med. 2018 Aug 30;26(1):70. doi: 10.1186/s13049-018-0538-6.
PubMed 30165909
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Versus Manual Chest Compression: A Retrospective Study in In-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT04422938
- Acronym / sponsor ID
- medybu-IN
- Conditions
- Cardiac Arrest, Resuscitation
- Keywords
- Cardiopulmonary Resuscitation, Chest compression, In-hospital, Mechanical, Manuel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 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
- 31 Dec 2017 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 9 Jun 2020 (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 in-hospital cardiac arrest cases.
Detailed description
In this study, the investigators analyzed cardiopulmonary resuscitations performed over a 2-year period in an emergency department of a training and research hospital and compared success of manual and mechanical chest compressions in terms of return of spontaneous circulation, 30-day survival, and hospital discharge. Investigators present the study as an in-hospital cardiac arrest study; however, all of the resuscitation performed in the cases included in the study were performed in the emergency department.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manuel compression | – | Other: Manuel chest compressions handled by cliniciansManuel chest compressions will be handled by clinicians |
| Mechanical compression | – | Device: LUCAS™ 2 Chest Compression SystemMechanical chest compressions will be handled via mechanical chest compression device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases with cardiac arrest in-hospital environment (in emergency department) and whose had manual or mechanical cardiopulmonary resuscitation in emergency department included in the study; data were collected hospital management information system and analyzed retropectively.
Key inclusion criteria (1 listed)
- Over 18 age Cardiac arrest cases In-hospital cardiac arrest cases Resuscitations performed in emergency department
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 |
|---|---|---|
| Manuel chest compressions handled by cliniciansCompressions will be handled by human efforts | Other | Manuel compression |
| LUCAS™ 2 Chest Compression SystemLUCAS-2 model piston-based mechanical chest compression device was used for mechanical chest compressions | Device | Mechanical compression |
Primary outcome
Mortality rate on the 30th day
Time frame: 30 days
Mortality rates from the hospital admission to the 30th day
Rate of the return of spontaneous circulation
Time frame: 5 minutes
Rate of return of the spontaneous circulation with duration at least five 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 9 Jun 2020.
- Background: PubMed 26976675Couper K, Yeung J, Nicholson T, Quinn T, Lall R, Perkins GD. Mechanical chest compression devices at in-hospital cardiac arrest: A systematic review and meta-analysis. Resuscitation. 2016 Jun;103:24-31. doi: 10.1016/j.resuscitation.2016.03.004. Epub 2016 Mar 11.
- Background: PubMed 30165909Couper K, Quinn T, Lall R, Devrell A, Orriss B, Seers K, Yeung J, Perkins GD; COMPRESS-RCT collaborators. Mechanical versus manual chest compressions in the treatment of in-hospital cardiac arrest patients in a non-shockable rhythm: a randomised controlled feasibility trial (COMPRESS-RCT). Scand J Trauma Resusc Emerg Med. 2018 Aug 30;26(1):70. doi: 10.1186/s13049-018-0538-6.
- 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 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 9 Jun 2020. 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?
Mortality rate 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 NCT04422938, which also lists 2 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 9 Jun 2020.