- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00951704
Evaluation of the Quality of Cardio-Pulmonary Resuscitation (CPR) in Cardiac Arrest Patients
December 12, 2018 updated by: Tampere University Hospital
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Turku, Finland, 20100
- Department of Anesthesiology and Intensive Care, Turku University Hospital
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Pirkanmaa
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Tampere, Pirkanmaa, Finland, 33521
- Tampere University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult population >18 years of age with cardiac arrest
Description
Inclusion Criteria:
- cardiac arrest
- > 18 years of age
Exclusion Criteria:
- < 18 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Cardiac arrest
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The success rate of current guidelines (depth and frequency of chest compression, epidemiology)
Time Frame: During the resuscitation
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During the resuscitation
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Quality of life after CA
Time Frame: 6 months
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Quality of life after CA is usually fairly good measurement of quality of resuscitation attempt
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Invasive arterial pressures, cerebral oxygenation (NIRS), EtCO2
Time Frame: During the resuscitation
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During the resuscitation
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survival of cardiac arrest
Time Frame: hospital discharge
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hospital discharge
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in hemodynamics, Change in cerebral saturation, Change in quality of CPR
Time Frame: During resuscitation
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During resuscitation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jyrki Tenhunen, MD, PhD, Critical Care Medicine Research Group
- Principal Investigator: Sanna Hoppu, MD, PhD, Tampere University Hospital
- Principal Investigator: Marko Sainio, MD, Turku University Hospital
- Study Director: Klaus Olkkola, MD, PhD, Department of Anesthesiology and Intensive Care, Helsinki University Hospital
- Principal Investigator: Heidi Hellevuo, MD, Tampere University Hospital
- Principal Investigator: Piritta Setälä, MD, Tampere University Hospital
- Study Director: Ilkka Virkkunen, MD, PhD, Tampere University Hospital
- Principal Investigator: Heidi Kangasniemi, MD, Tampere University Hospital
- Principal Investigator: Joonas Tamminen, Tampere University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Setala 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.
- Setala 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.
- Sainio 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.
- Sainio 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.
- Sainio 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.
- Hoppu 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
July 31, 2009
First Submitted That Met QC Criteria
August 3, 2009
First Posted (Estimate)
August 4, 2009
Study Record Updates
Last Update Posted (Actual)
December 13, 2018
Last Update Submitted That Met QC Criteria
December 12, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R08116
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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