- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01258244
Arizona Prehospital CPR Quality Improvement Project
The quality of cardiopulmonary resuscitation (CPR) provided to patients with out-of-hospital cardiac arrest (OHCA) is often suboptimal. There now exist monitors/defibrillators that allow for the measurement and real time feedback of the quality of chest compressions and ventilations. In addition to giving the prehospital provider the benefit of real time CPR quality feedback via voice and visual cues, the CPR quality data acquired using these devices can be utilized as part of an on-going quality assurance/quality improvement program.
The first objective of the proposed project is to quantify the quality of chest compressions and ventilations provided in the state of Arizona to patients with OHCA and to determine whether the quality of CPR is related to patient outcome from OHCA.
A second objective of this project is to determine whether use of audiovisual feedback improves both CPR quality and patient outcome in the pre-hospital setting.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Phase I: In the first phase of the project, the EMS systems will utilize the E-series units to treat all patients with OHCA. The audiovisual feedback prompts will be inactivated during this phase. The EMS providers will be instructed to follow the standard CCR protocol, as is currently the practice. Aside from the change in monitor/defibrillator equipment, the treatment of OHCA patients during this phase will be identical to the treatment that is currently performed. The quality of CPR will be measured using the accelerometer-based system. The data will be stored in the defibrillator and will be downloaded upon completion of the call. The first phase will be conducted for approximately 6 months from the time each site initiates the use of the E-series monitor/defibrillators.
Phase 2:In the second phase of the project, the EMS providers will undergo training on how to use the audiovisual feedback prompts. The providers will continue to treat patients according to the CCR protocol but will now receive audio and/or visual feedback on the quality of CPR that they are performing. The providers will select the preferred feedback method(s) - audio, visual or both. As in phase I, the CPR data will be stored in the defibrillator and will be downloaded upon completion of the call.
The total number of EMS personnel who will be trained is approximately 450. In Phase I, there were 219 OHCAs (80% from Mesa Fire Dept, and 20% from Guardian Medical Transport). So far in Phase II, there have been about 100 OHCAs.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Arizona
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Flagstaff, Arizona, United States, 86001
- Guardian Medical Transport
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Mesa, Arizona, United States, 85201
- Mesa Fire Department
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Emergency Medical Services personnel at 8 fire departments in AZ who treat patients with out of hospital cardiac arrest (OHCA)
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Audiovisual feedback on CPR
EMS technicians will receive audiovisual feedback from the ZOLL device on depth, frequency, and interruptions to cardiac compressions
|
EMTs will get audiovisual feedback on CPR technique during CPR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of chest compressions
Time Frame: Phase I - 6 months; Phase II - 20 months
|
Depth of chest compressions, rate of chest compressions, and interruptions in chest compressions
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Phase I - 6 months; Phase II - 20 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival to hospital discharge
Time Frame: Phase I - 6 months; Phase II - 20 months
|
Did the patient survive to hospital discharge?
(Yes or no--dichotomous measure)
|
Phase I - 6 months; Phase II - 20 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bentley J Bobrow, MD, Arizona Department of Health Services, Maricopa Integrated Health System
Publications and helpful links
General 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.
- Handley AJ, Handley SA. Improving CPR performance using an audible feedback system suitable for incorporation into an automated external defibrillator. Resuscitation. 2003 Apr;57(1):57-62. doi: 10.1016/s0300-9572(02)00400-8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-118
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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