Cardiac ArrestPhase 2NCT00138996
Quality of Cardiopulmonary Resuscitation Without and With Defibrillator Feedback
A Phase 2 study testing automated direct feedback on CPR from defibrillator in people with Cardiac Arrest, run by University of Oslo at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- automated direct feedback on CPR from defibrillator
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Mar 2002to Jun 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiac arrest out-of-hospital
Who cannot join
- < 18 years old
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Can the Quality of Cardiopulmonary Resuscitation Improve With Direct Online Feedback From the Defibrillator to the Rescuers on Their Resuscitation Efforts
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
Read the 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
- Conditions
- Cardiac Arrest
- Being tested
- automated direct feedback on CPR from defibrillator
- Keywords
- cardiac arrest, resuscitation, quality, feedback, training
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
automated direct feedback on CPR from defibrillatorDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
fraction of time without CPR
chest compression depth
chest compression frequency
chest compression/decompression duty cycle
ventilation frequency
Secondary outcomes (1)
rate of return of spontaneous circulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startMar 2002
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Laerdal Medical, Ullevaal University Hospital, Health Region East, Norway, Norwegian Air Ambulance Foundation, London Ambulance Service, Stockholm Ambulance Service, University of Chicago
- Investigators
- Petter A Steen, Principal investigator, University of Oslo, Ulleval University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138996
- Sponsor's protocol ID
- 402-01139
- Other IDs
- 2002-OSL-MDD-0009 (DNVeritas)
- Status last verified
- Aug 2007
- First submitted
- 29 Aug 2005
- Last updated
- 27 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15657322Kramer-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.
PubMed 17241734Kramer-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.
PubMed 17070980
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Quality of Cardiopulmonary Resuscitation Improve With Direct Online Feedback From the Defibrillator to the Rescuers on Their Resuscitation Efforts
- ClinicalTrials.gov ID
- NCT00138996
- Acronym / sponsor ID
- 402-01139
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, resuscitation, quality, feedback, training
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Laerdal Medical, Ullevaal University Hospital, Health Region East, Norway, Norwegian Air Ambulance Foundation, London Ambulance Service, Stockholm Ambulance Service, University of Chicago
- Study start
- Mar 2002
- Study completion
- Jun 2006 (actual)
- First posted
- 30 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cardiac arrest out-of-hospital
Key exclusion criteria (1 listed)
- < 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| automated direct feedback on CPR from defibrillator | Device | – |
Primary outcome
fraction of time without CPR
chest compression depth
chest compression frequency
chest compression/decompression duty cycle
ventilation frequency
1 secondary outcome
rate of return of spontaneous circulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2007.
- Results publication: PubMed 15657322Wik 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.
- Derived from this study: PubMed 17241734Kramer-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.
- Derived from this study: PubMed 17070980Kramer-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petter A Steen principal investigator
University of Oslo, Ulleval University Hospital
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing automated direct feedback on CPR from defibrillator in people with Cardiac Arrest, run by University of Oslo at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fraction of time without CPR. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00138996, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2007.