Cardiac ArrestNCT00951704
Evaluation of the Quality of Cardio-Pulmonary Resuscitation (CPR) in Cardiac Arrest Patients
An observational study of Cardiac Arrest, run by Tampere University Hospital at 2 sites in Finland.
Trial summary
The prognosis of cardiac arrest patients is generally poor. Recent studies have showed that the high quality of CPR increases the survival after cardiac arrest. Therefore the investigators planned this prospective observational study to determine the epidemiology of sudden cardiac arrest in the prehospital setting of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- How many people
- 1,000 participants
- Where
- 2 sitesFinland
- Study dates
- Nov 2008to Dec 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: Adult population >18 years of age with cardiac arrest
Who may be able to join
- cardiac arrest
- > 18 years of age
Who cannot join
- < 18 years of age
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Tampere University Hospital
Tampere, Pirkanmaa, 33521
Department of Anesthesiology and Intensive Care, Turku University Hospital
Turku, 20100
About this study
Official title: Evaluating the Quality of Prehospital and In-hospital Cardio-pulmonary Resuscitation - Comparing the Compressions to Concurrent Vital Signs (Invasive Blood Pressure, Cerebral Oxygen Saturation, EtCO2) and Iatrogenic Injuries Associated to Chest Compressions.
The prognosis of cardiac arrest patients is generally poor. Recent studies have showed that the high quality of CPR increases the survival after cardiac arrest. Therefore the investigators planned this prospective observational study to determine the epidemiology of sudden cardiac arrest in the prehospital setting of Tampere area, the quality of the CPR, and also the associations between depth and frequency of chest compressions and invasive arterial pressure, EtCO2,cerebral oxygenation and iatrogenic injuries associated to chest compressions 1) in patients resuscitated out of hospital by emergency medical service's (EMS's) personals and 2) in-hospital by hospital resuscitation team members. In addition, the investigators will analyze the effects of the chosen method of resuscitation on critical vital signs (Etco2 and invasive pressures): closed-chest CPR is compared to open-chest CPR, or mechanical CPR with a device (AutoPulse-CPR, Cardio Pump) compared to manual CPR guided with quality CPR device. The results will give the investigators important insights into the haemodynamics of CPR which may guide future strategies for the management of cardiac arrest. The research group is also interested in CPR related injuries and mattress effect. Quality of life after CA is evaluated among survivals and the cause of death among non-survivors.
- Conditions
- Cardiac Arrest
- Keywords
- CPR, Tissue Perfusion, invasive arterial pressure, exhaled carbon dioxide, Quality of life, Quality of chest compressions, Epidemiology of sudden cardiac arrest(OHCA)
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac arrest | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of current guidelines (depth and frequency of chest compression, epidemiology)
Measured: During the resuscitation
Quality of life after CA
Quality of life after CA is usually fairly good measurement of quality of resuscitation attempt
Measured: 6 months
Secondary outcomes (2)
Invasive arterial pressures, cerebral oxygenation (NIRS), EtCO2
Measured: During the resuscitation
survival of cardiac arrest
Measured: hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startNov 2008
- Primary completionDec 2015
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 Tampere University HospitalThe 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, Uppsala University
- Responsible party
- Sponsor
- Investigators
- Jyrki Tenhunen, MD, PhD, Study director, Critical Care Medicine Research GroupSanna Hoppu, MD, PhD, Principal investigator, Tampere University HospitalMarko Sainio, MD, Principal investigator, Turku University HospitalKlaus Olkkola, MD, PhD, Study director, Department of Anesthesiology and Intensive Care, Helsinki University HospitalHeidi Hellevuo, MD, Principal investigator, Tampere University HospitalPiritta Setälä, MD, Principal investigator, Tampere University HospitalIlkka Virkkunen, MD, PhD, Study director, Tampere University HospitalHeidi Kangasniemi, MD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951704
- Sponsor's protocol ID
- R08116
- Status last verified
- Dec 2018
- First submitted
- 31 Jul 2009
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kangasniemi H, Setala P, Huhtala H, Kamarainen A, Virkkunen I, Jamsen E, Yli-Hankala A, Hoppu S. Out-of-hospital cardiac arrests in nursing homes and primary care facilities in Pirkanmaa, Finland. Acta Anaesthesiol Scand. 2018 Oct;62(9):1297-1303. doi: 10.1111/aas.13152. Epub 2018 May 29.
PubMed 29845604Setala P, Hellevuo H, Huhtala H, Kamarainen A, Tirkkonen J, Hoppu S. Risk factors for cardiopulmonary resuscitation-related injuries sustained during out-of-hospital cardiac arrests. Acta Anaesthesiol Scand. 2018 Oct;62(9):1290-1296. doi: 10.1111/aas.13155. Epub 2018 May 24.
PubMed 29797706Setala PA, Virkkunen IT, Kamarainen AJ, Huhtala HSA, Virta JS, Yli-Hankala AM, Hoppu SE. End-tidal carbon dioxide output in manual cardiopulmonary resuscitation versus active compression-decompression device during prehospital quality controlled resuscitation: a case series study. Emerg Med J. 2018 Jul;35(7):428-432. doi: 10.1136/emermed-2017-207103. Epub 2018 May 16.
PubMed 29769232Sainio M, Hoppu S, Huhtala H, Eilevstjonn J, Olkkola KT, Tenhunen J. Simultaneous beat-to-beat assessment of arterial blood pressure and quality of cardiopulmonary resuscitation in out-of-hospital and in-hospital settings. Resuscitation. 2015 Nov;96:163-9. doi: 10.1016/j.resuscitation.2015.08.004. Epub 2015 Aug 24.
PubMed 26310837Sainio M, Sutton RM, Huhtala H, Eilevstjonn J, Tenhunen J, Olkkola KT, Nadkarni VM, Hoppu S. Association of arterial blood pressure and CPR quality in a child using three different compression techniques, a case report. Scand J Trauma Resusc Emerg Med. 2013 Jul 2;21:51. doi: 10.1186/1757-7241-21-51.
PubMed 23819769Sainio M, Kamarainen A, Huhtala H, Aaltonen P, Tenhunen J, Olkkola KT, Hoppu S. Real-time audiovisual feedback system in a physician-staffed helicopter emergency medical service in Finland: the quality results and barriers to implementation. Scand J Trauma Resusc Emerg Med. 2013 Jul 1;21:50. doi: 10.1186/1757-7241-21-50.
PubMed 23816325Hoppu S, Sainio M, Huhtala H, Eilevstjonn J, Tenhunen J, Olkkola KT. Blood pressure during resuscitation in man--the effect of pause during rhythm analysis revisited. Resuscitation. 2011 Nov;82(11):1460-3. doi: 10.1016/j.resuscitation.2011.06.005. Epub 2011 Jun 17.
PubMed 21764499
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Quality of Prehospital and In-hospital Cardio-pulmonary Resuscitation - Comparing the Compressions to Concurrent Vital Signs (Invasive Blood Pressure, Cerebral Oxygen Saturation, EtCO2) and Iatrogenic Injuries Associated to Chest Compressions.
- ClinicalTrials.gov ID
- NCT00951704
- Acronym / sponsor ID
- R08116
- Conditions
- Cardiac Arrest
- Keywords
- CPR, Tissue Perfusion, invasive arterial pressure, exhaled carbon dioxide, Quality of life, Quality of chest compressions, Epidemiology of sudden cardiac arrest(OHCA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital, Uppsala University
- Study start
- Nov 2008
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 4 Aug 2009 (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 prognosis of cardiac arrest patients is generally poor. Recent studies have showed that the high quality of CPR increases the survival after cardiac arrest. Therefore the investigators planned this prospective observational study to determine the epidemiology of sudden cardiac arrest in the prehospital setting of Tampere area, the quality of the CPR, and also the associations between depth and frequency of chest compressions and invasive arterial pressure, EtCO2,cerebral oxygenation and iatrogenic injuries associated to chest compressions 1) in patients resuscitated out of hospital by emergency medical service's (EMS's) personals and 2) in-hospital by hospital resuscitation team members. In addition, the investigators will analyze the effects of the chosen method of resuscitation on critical vital signs (Etco2 and invasive pressures): closed-chest CPR is compared to open-chest CPR, or mechanical CPR with a device (AutoPulse-CPR, Cardio Pump) compared to manual CPR guided with quality CPR device. The results will give the investigators important insights into the haemodynamics of CPR which may guide future strategies for the management of cardiac arrest. The research group is also interested in CPR related injuries and mattress effect. Quality of life after CA is evaluated among survivals and the cause of death among non-survivors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac arrest | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population >18 years of age with cardiac arrest
Key inclusion criteria (2 listed)
- cardiac arrest
- > 18 years of age
Key exclusion criteria (1 listed)
- < 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The success rate of current guidelines (depth and frequency of chest compression, epidemiology)
Time frame: During the resuscitation
Quality of life after CA
Time frame: 6 months
Quality of life after CA is usually fairly good measurement of quality of resuscitation attempt
2 secondary outcomes
Invasive arterial pressures, cerebral oxygenation (NIRS), EtCO2
Time frame: During the resuscitation
survival of cardiac arrest
Time frame: hospital discharge
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 13 Dec 2018.
- Derived from this study: PubMed 29845604Kangasniemi H, Setala P, Huhtala H, Kamarainen A, Virkkunen I, Jamsen E, Yli-Hankala A, Hoppu S. Out-of-hospital cardiac arrests in nursing homes and primary care facilities in Pirkanmaa, Finland. Acta Anaesthesiol Scand. 2018 Oct;62(9):1297-1303. doi: 10.1111/aas.13152. Epub 2018 May 29.
- Derived from this study: PubMed 29797706Setala P, Hellevuo H, Huhtala H, Kamarainen A, Tirkkonen J, Hoppu S. Risk factors for cardiopulmonary resuscitation-related injuries sustained during out-of-hospital cardiac arrests. Acta Anaesthesiol Scand. 2018 Oct;62(9):1290-1296. doi: 10.1111/aas.13155. Epub 2018 May 24.
- Derived from this study: PubMed 29769232Setala PA, Virkkunen IT, Kamarainen AJ, Huhtala HSA, Virta JS, Yli-Hankala AM, Hoppu SE. End-tidal carbon dioxide output in manual cardiopulmonary resuscitation versus active compression-decompression device during prehospital quality controlled resuscitation: a case series study. Emerg Med J. 2018 Jul;35(7):428-432. doi: 10.1136/emermed-2017-207103. Epub 2018 May 16.
- Derived from this study: PubMed 26310837Sainio M, Hoppu S, Huhtala H, Eilevstjonn J, Olkkola KT, Tenhunen J. Simultaneous beat-to-beat assessment of arterial blood pressure and quality of cardiopulmonary resuscitation in out-of-hospital and in-hospital settings. Resuscitation. 2015 Nov;96:163-9. doi: 10.1016/j.resuscitation.2015.08.004. Epub 2015 Aug 24.
- Derived from this study: PubMed 23819769Sainio M, Sutton RM, Huhtala H, Eilevstjonn J, Tenhunen J, Olkkola KT, Nadkarni VM, Hoppu S. Association of arterial blood pressure and CPR quality in a child using three different compression techniques, a case report. Scand J Trauma Resusc Emerg Med. 2013 Jul 2;21:51. doi: 10.1186/1757-7241-21-51.
- Derived from this study: PubMed 23816325Sainio M, Kamarainen A, Huhtala H, Aaltonen P, Tenhunen J, Olkkola KT, Hoppu S. Real-time audiovisual feedback system in a physician-staffed helicopter emergency medical service in Finland: the quality results and barriers to implementation. Scand J Trauma Resusc Emerg Med. 2013 Jul 1;21:50. doi: 10.1186/1757-7241-21-50.
- Derived from this study: PubMed 21764499Hoppu S, Sainio M, Huhtala H, Eilevstjonn J, Tenhunen J, Olkkola KT. Blood pressure during resuscitation in man--the effect of pause during rhythm analysis revisited. Resuscitation. 2011 Nov;82(11):1460-3. doi: 10.1016/j.resuscitation.2011.06.005. Epub 2011 Jun 17.
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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.
Jyrki Tenhunen, MD, PhD study director
Critical Care Medicine Research Group
Sanna Hoppu, MD, PhD principal investigator
Tampere University Hospital
Marko Sainio, MD principal investigator
Turku University Hospital
2 sites 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 Tampere University Hospital at 2 sites in Finland.
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 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 13 Dec 2018. 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 Finland. 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?
The success rate of current guidelines (depth and frequency of chest compression, epidemiology) (time frame: During the resuscitation). 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 NCT00951704, which also lists 7 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 13 Dec 2018.