Cardiac ArrestNCT01245699
MIHS Emergency Department CPR Quality Improvement Project
A study testing scenario-based training, real-time audiovisual CPR feedback, and post-event debriefing in people with Cardiac Arrest, run by Valleywise Health at 1 site in United States.
Trial summary
The investigators will quantify the quality of chest compressions provided in the Emergency Department and determine whether the quality of chest compressions is related to patient outcome. 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?
- scenario-based training, real-time audiovisual CPR feedback, and post-event debriefing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2010to 9 Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18 years old or older
Who cannot join
- less than 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Maricopa Integrated Health System
Phoenix, Arizona, 85008
About this study
The investigators will quantify the quality of chest compressions provided in the Emergency Department and determine whether the quality of chest compressions is related to patient outcome. The quality of chest compressions and patient outcomes will be assessed both before and after the introduction of audiovisual feedback in real time.
Read the detailed description
The Emergency Department will be using E-series unit manufactured by ZOLL Medical Group (Chelmsford, MA). These units are equipped with an accelerometer-based system that allows for measurement of chest compression depth and rate. These units are also equipped with RealCPRHelp, and FDA-approved technology that provides real-time audiovisual feedback to providers on the quality of chest compressions.
In the first phase of the project, the ED providers will utilize the E-series units to treat all patients requiring chest compressions.
- Conditions
- Cardiac Arrest
- Being tested
- scenario-based training, real-time audiovisual CPR feedback, and post-event debriefing
- Keywords
- Cardiac arrest, CPR, quality improvement
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scenario-based training, real-time audiovisual CPR feedback, and post-event debriefingBehavioural
scenario-based training for CPR, real-time audiovisual CPR feedback using R Series monitor-defibrillator during treatment, and post-event debriefing
| Study group | Role | What they receive |
|---|---|---|
| Before RTAVF and post-event debriefing | No intervention | Before scenario-based training, real-time audiovisual CPR feedback, and post-event debriefing |
| After RTAVF and post-event debriefing | Active comparator | After scenario-based training, real-time audiovisual CPR feedback, and post-event debriefing Receives: Behavioral: scenario-based training, real-time audiovisual CPR feedback, and post-event debriefing |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPR Quality-compression Depth
Measurement of chest compression depth
Measured: during CPR
CPR Quality-percent of >51mm Compressions
Percent of Chest Compressions greater than 51mm
Measured: during CPR
CPR Quality
Chest Compression Release Velocity
Measured: during CPR
CPR Quality-compression Fraction
Chest Compression Fraction indicating the percentage of time in which chest compressions are done by rescuers during a cardiac arrest
Measured: During CPR
CPR Quality-Chest Compression Rate
Mean Chest Compression Rate
Measured: During CPR
CPR Quality- Pre-shock Pause
Pre-shock pause: time from cessation of CPR to shock delivery
Measured: During CPR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2010 (estimated)
- Study start9 Jun 2010
- Primary completion5 Nov 2015
- Study completion9 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Chest Compression before and after RealCPRHelp
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valleywise Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bentley J Bobrow, MD, Principal investigator, Valleywise Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245699
- Sponsor's protocol ID
- 2010-037
- Status last verified
- Jan 2019
- First submitted
- 19 Nov 2010
- Last updated
- 26 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bobrow BJ, Clark LL, Ewy GA, Chikani V, Sanders AB, Berg RA, Richman PB, Kern KB. Minimally interrupted cardiac resuscitation by emergency medical services for out-of-hospital cardiac arrest. JAMA. 2008 Mar 12;299(10):1158-65. doi: 10.1001/jama.299.10.1158.
PubMed 18334691
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIHS Emergency Department CPR Quality Improvement Project
- ClinicalTrials.gov ID
- NCT01245699
- Acronym / sponsor ID
- 2010-037
- Conditions
- Cardiac Arrest
- Keywords
- Cardiac arrest, CPR, quality improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Valleywise HealthUniversity, hospital or other
- Study start
- 9 Jun 2010 (actual)
- Primary completion
- 5 Nov 2015 (actual)
- Study completion
- 9 Mar 2016 (actual)
- First posted
- 22 Nov 2010 (estimated)
- Results
- Posted 26 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will quantify the quality of chest compressions provided in the Emergency Department and determine whether the quality of chest compressions is related to patient outcome. The quality of chest compressions and patient outcomes will be assessed both before and after the introduction of audiovisual feedback in real time.
Detailed description
The Emergency Department will be using E-series unit manufactured by ZOLL Medical Group (Chelmsford, MA). These units are equipped with an accelerometer-based system that allows for measurement of chest compression depth and rate. These units are also equipped with RealCPRHelp, and FDA-approved technology that provides real-time audiovisual feedback to providers on the quality of chest compressions.
In the first phase of the project, the ED providers will utilize the E-series units to treat all patients requiring chest compressions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Chest Compression before and after RealCPRHelp
| Arm | Type | Receives |
|---|---|---|
| Before RTAVF and post-event debriefing | No intervention | –Before scenario-based training, real-time audiovisual CPR feedback, and post-event debriefing |
| After RTAVF and post-event debriefing | Active comparator | Behavioral: scenario-based training, real-time audiovisual CPR feedback, and post-event debriefingAfter scenario-based training, real-time audiovisual CPR feedback, and post-event debriefing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years old or older
Key exclusion criteria (1 listed)
- less than 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 |
|---|---|---|
| scenario-based training, real-time audiovisual CPR feedback, and post-event debriefingscenario-based training for CPR, real-time audiovisual CPR feedback using R Series monitor-defibrillator during treatment, and post-event debriefing | Behavioural | After RTAVF and post-event debriefing |
Primary outcome
CPR Quality-compression Depth
Time frame: during CPR
Measurement of chest compression depth
CPR Quality-percent of >51mm Compressions
Time frame: during CPR
Percent of Chest Compressions greater than 51mm
CPR Quality
Time frame: during CPR
Chest Compression Release Velocity
CPR Quality-compression Fraction
Time frame: During CPR
Chest Compression Fraction indicating the percentage of time in which chest compressions are done by rescuers during a cardiac arrest
CPR Quality-Chest Compression Rate
Time frame: During CPR
Mean Chest Compression Rate
CPR Quality- Pre-shock Pause
Time frame: During CPR
Pre-shock pause: time from cessation of CPR to shock delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18334691Bobrow BJ, Clark LL, Ewy GA, Chikani V, Sanders AB, Berg RA, Richman PB, Kern KB. Minimally interrupted cardiac resuscitation by emergency medical services for out-of-hospital cardiac arrest. JAMA. 2008 Mar 12;299(10):1158-65. doi: 10.1001/jama.299.10.1158.
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Cardiac Arrest
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.
Bentley J Bobrow, MD principal investigator
Valleywise Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scenario-based training, real-time audiovisual CPR feedback, and post-event debriefing in people with Cardiac Arrest, run by Valleywise Health at 1 site in United States.
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 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
CPR Quality-compression Depth (time frame: during CPR). The study lists 6 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 NCT01245699, which also lists 1 linked publication.
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 26 Apr 2019.