Quality of Cardiopulmonary Resuscitation Without and With Defibrillator Feedback
Primary Purpose
Cardiac Arrest
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
automated direct feedback on CPR from defibrillator
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Arrest focused on measuring cardiac arrest, resuscitation, quality, feedback, training
Eligibility Criteria
Inclusion Criteria: Cardiac arrest out-of-hospital Exclusion Criteria: < 18 years old
Sites / Locations
- Ulleval University Hospital
- Stockholm Ambulance Service
- London Ambulance Service
Outcomes
Primary Outcome Measures
fraction of time without CPR
chest compression depth
chest compression frequency
chest compression/decompression duty cycle
ventilation frequency
Secondary Outcome Measures
rate of return of spontaneous circulation
Full Information
NCT ID
NCT00138996
First Posted
August 29, 2005
Last Updated
August 24, 2007
Sponsor
University of Oslo
Collaborators
Laerdal Medical, Ullevaal University Hospital, Health Region East, Norway, Norwegian Air Ambulance Foundation, London Ambulance Service, Stockholm Ambulance Service, University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT00138996
Brief Title
Quality of Cardiopulmonary Resuscitation Without and With Defibrillator Feedback
Official Title
Can the Quality of Cardiopulmonary Resuscitation Improve With Direct Online Feedback From the Defibrillator to the Rescuers on Their Resuscitation Efforts
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Oslo
Collaborators
Laerdal Medical, Ullevaal University Hospital, Health Region East, Norway, Norwegian Air Ambulance Foundation, London Ambulance Service, Stockholm Ambulance Service, University of Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Quality of bystander cardiopulmonary resuscitation (CPR) affect patient survival. Quality of professional CPR on patients has not been studied in detail, but it is regularly reported that the quality when tested on manikins deteriorates dramatically within months after training. Automated direct feedback on CPR quality from manikins brings quality back within a couple of minutes. Similar feedback has been incorporated into a defibrillator which also monitors quality of CPR. We hypothesise that quality of professional clinical CPR improves with such feedback
Detailed Description
Defibrillators which monitor quality of CPR via changes in thoracic impedance (for ventilation) and movement of the sternum employing an accelerometer (for chest compressions) will be employed in ambulances in Akershus county (Norway), Stockholm (Sweden) and London (UK). During phase 1 quality of CPR will be monitored without feedback from the defibrillator. During phase 2 the ambulance personnel will receive feedback via the defibrillator. During phase 3 the ambulance personnel will be retrained with particular attention to the quality problems that became apparent in phase 3.
Quality of CPR will be continuously recorded by the defibrillators and the data collected and sent via internet to Laerdal Medical. All other cardiac arrest data including survival will be recorded using standard datasets for cardiac arrest research as developed by a task force with members from the organisations in International Liaison Committee on resuscitation (Utstein guidelines). The data will be annotated and analyzed in detail by researchers at University of Oslo
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
cardiac arrest, resuscitation, quality, feedback, training
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
automated direct feedback on CPR from defibrillator
Primary Outcome Measure Information:
Title
fraction of time without CPR
Title
chest compression depth
Title
chest compression frequency
Title
chest compression/decompression duty cycle
Title
ventilation frequency
Secondary Outcome Measure Information:
Title
rate of return of spontaneous circulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cardiac arrest out-of-hospital
Exclusion Criteria:
< 18 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petter A Steen
Organizational Affiliation
University of Oslo, Ulleval University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ulleval University Hospital
City
Oslo
ZIP/Postal Code
N-0407
Country
Norway
Facility Name
Stockholm Ambulance Service
City
Stockholm
Country
Sweden
Facility Name
London Ambulance Service
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
15657322
Citation
Wik L, Kramer-Johansen J, Myklebust H, Sorebo H, Svensson L, Fellows B, Steen PA. Quality of cardiopulmonary resuscitation during out-of-hospital cardiac arrest. JAMA. 2005 Jan 19;293(3):299-304. doi: 10.1001/jama.293.3.299.
Results Reference
result
PubMed Identifier
17241734
Citation
Kramer-Johansen J, Edelson DP, Abella BS, Becker LB, Wik L, Steen PA. Pauses in chest compression and inappropriate shocks: a comparison of manual and semi-automatic defibrillation attempts. Resuscitation. 2007 May;73(2):212-20. doi: 10.1016/j.resuscitation.2006.09.006. Epub 2007 Jan 22.
Results Reference
derived
PubMed Identifier
17070980
Citation
Kramer-Johansen J, Myklebust H, Wik L, Fellows B, Svensson L, Sorebo H, Steen PA. Quality of out-of-hospital cardiopulmonary resuscitation with real time automated feedback: a prospective interventional study. Resuscitation. 2006 Dec;71(3):283-92. doi: 10.1016/j.resuscitation.2006.05.011. Epub 2006 Oct 27.
Results Reference
derived
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Quality of Cardiopulmonary Resuscitation Without and With Defibrillator Feedback
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