Evaluation of the Quality of Cardio-Pulmonary Resuscitation (CPR) in Cardiac Arrest Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Tampere University Hospital
Sponsor:
Collaborators:
Turku University Hospital
Uppsala University
Information provided by (Responsible Party):
Arvi Yli-Hankala, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT00951704
First received: July 31, 2009
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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.


Condition
Cardiac Arrest

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating the Quality of Prehospital and In-hospital Cardio-pulmonary Resuscitation by Reviewing Defibrillator Records - Comparing the Compressions to Concurrent Vital Signs (Invasive Blood Pressure, Cerebral Oxygen Saturation, EtCO2) and Iatrogenic Injuries Associated to Chest Compressions.

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • The success rate of current guidelines (depth and frequency of chest compression, epidemiology) [ Time Frame: During the resuscitation ] [ Designated as safety issue: No ]
  • Quality of life after CA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Quality of life after CA is usually fairly good measurement of quality of resuscitation attempt


Secondary Outcome Measures:
  • Invasive arterial pressures, cerebral oxygenation (NIRS), EtCO2 [ Time Frame: During the resuscitation ] [ Designated as safety issue: No ]
  • survival of cardiac arrest [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in hemodynamics, Change in cerebral saturation, Change in quality of CPR [ Time Frame: During resuscitation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: November 2008
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiac arrest

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult population >18 years of age with cardiac arrest

Criteria

Inclusion Criteria:

  • cardiac arrest
  • > 18 years of age

Exclusion Criteria:

  • < 18 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951704

Contacts
Contact: Sanna Hoppu, MD, PhD +358503624711 sanna.hoppu@fimnet.fi
Contact: Marko Sainio, MD +358505342399 marko.sainio@fimnet.fi

Locations
Finland
Critical Care Medicine Research Group, Tampere University Hospital Recruiting
Tampere, Pirkanmaa, Finland, 33521
Contact: Sanna Hoppu, MD, PhD    +358503624711    sanna.hoppu@fimnet.fi   
Contact: Marko Sainio, MB    +358505342399    marko.sainio@fimnet.fi   
Department of Anesthesiology and Intensive Care, Turku University Hospital Recruiting
Turku, Finland, 20100
Contact: Klaus Olkkola, MD, PhD    +358407583655    klaus.olkkola@tyks.fi   
Sponsors and Collaborators
Tampere University Hospital
Turku University Hospital
Uppsala University
Investigators
Study Director: Jyrki Tenhunen, MD, PhD Critical Care Medicine Research Group
Principal Investigator: Sanna Hoppu, MD, PhD Critical Care Medicine Research Group
Principal Investigator: Marko Sainio, MD Critical Care Medicine Research Group
Study Director: Klaus Olkkola, MD, PhD Turku University Hospital
Principal Investigator: Heidi Hellevuo, MB Critical Care Medicine Research Group
Principal Investigator: Piritta Setälä, MD Tampere University Hospital
Study Director: Ilkka Virkkunen, MD, PhD Tampere University Hospital
  More Information

No publications provided by Tampere University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arvi Yli-Hankala, MD, PhD, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT00951704     History of Changes
Other Study ID Numbers: R08116
Study First Received: July 31, 2009
Last Updated: April 15, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by Tampere University Hospital:
Open-chest
CPR
Tissue Perfusion
invasive arterial pressure
exhaled carbon dioxide
Quality of life
Quality of chest compressions
Epidemiology of sudden cardiac arrest(OHCA)

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014