Quality of Cardiopulmonary Resuscitation Without and With Defibrillator Feedback

Cardiac Arrest Clinical Trial

Official title:

Can the Quality of Cardiopulmonary Resuscitation Improve With Direct Online Feedback From the Defibrillator to the Rescuers on Their Resuscitation Efforts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00138996
• Other study ID #: 402-01139
• Secondary ID: 2002-OSL-MDD-000
• Status: Completed
• Phase: Phase 2
• First received: August 29, 2005
• Last updated: August 24, 2007
• Start date: March 2002
• Est. completion date: June 2006

Study information

• Verified date: August 2007
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cardiac arrest out-of-hospital

Exclusion Criteria:

• < 18 years old

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Device:
• automated direct feedback on CPR from defibrillator

Locations

Country	Name	City	State
Norway	Ulleval University Hospital	Oslo
Sweden	Stockholm Ambulance Service	Stockholm
United Kingdom	London Ambulance Service	London

Sponsors (8)

Lead Sponsor	Collaborator
University of Oslo	Health Region East, Norway, Laerdal Medical, London Ambulance Service, Norwegian Air Ambulance Foundation, Stockholm Ambulance Service, Ullevaal University Hospital, University of Chicago

Countries where clinical trial is conducted

Norway,  Sweden,  United Kingdom, 

References & Publications (1)

Wik L, Kramer-Johansen J, Myklebust H, Sørebø 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fraction of time without CPR
Primary	chest compression depth
Primary	chest compression frequency
Primary	chest compression/decompression duty cycle
Primary	ventilation frequency
Secondary	rate of return of spontaneous circulation