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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00951704
Recruitment Status : Completed
First Posted : August 4, 2009
Last Update Posted : December 13, 2018
Sponsor:
Collaborators:
Turku University Hospital
Uppsala University
Information provided by (Responsible Party):
Tampere University Hospital

Tracking Information
First Submitted Date July 31, 2009
First Posted Date August 4, 2009
Last Update Posted Date December 13, 2018
Study Start Date November 2008
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2013)
  • 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
Original Primary Outcome Measures
 (submitted: August 3, 2009)
The success rate of current guidelines (depth and frequency of chest compression) [ Time Frame: During the resuscitation ]
Change History
Current Secondary Outcome Measures
 (submitted: April 15, 2013)
  • Invasive arterial pressures, cerebral oxygenation (NIRS), EtCO2 [ Time Frame: During the resuscitation ]
  • survival of cardiac arrest [ Time Frame: hospital discharge ]
Original Secondary Outcome Measures
 (submitted: August 3, 2009)
Invasive arterial pressures, cerebral oxygenation (NIRS) [ Time Frame: During the resuscitation ]
Current Other Pre-specified Outcome Measures
 (submitted: April 15, 2013)
Change in hemodynamics, Change in cerebral saturation, Change in quality of CPR [ Time Frame: During resuscitation ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of the Quality of Cardio-Pulmonary Resuscitation (CPR) in Cardiac Arrest Patients
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.
Brief 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 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult population >18 years of age with cardiac arrest
Condition Cardiac Arrest
Intervention Not Provided
Study Groups/Cohorts Cardiac arrest
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: April 28, 2017)
1000
Original Estimated Enrollment
 (submitted: August 3, 2009)
100
Actual Study Completion Date December 2018
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • cardiac arrest
  • > 18 years of age

Exclusion Criteria:

  • < 18 years of age
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Finland
Removed Location Countries  
 
Administrative Information
NCT Number NCT00951704
Other Study ID Numbers R08116
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Tampere University Hospital
Original Responsible Party Sanna Hoppu, MD, PhD, Critical Care Medicine Research Group, Tampere University Hospital
Current Study Sponsor Tampere University Hospital
Original Study Sponsor Same as current
Collaborators
  • Turku University Hospital
  • Uppsala University
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
PRS Account Tampere University Hospital
Verification Date December 2018