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Arizona Prehospital CPR Quality Improvement Project

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ClinicalTrials.gov Identifier: NCT01258244
Recruitment Status : Recruiting
First Posted : December 10, 2010
Last Update Posted : November 18, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease
Out-of-Hospital Cardiac Arrest

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 Design

Study Type : Observational
Estimated Enrollment : 450 participants
Time Perspective: Prospective
Official Title: Arizona Prehospital CPR Quality Improvement Project
Study Start Date : May 2010
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Audiovisual feedback on CPR
EMS technicians will receive audiovisual feedback from the ZOLL device on depth, frequency, and interruptions to cardiac compressions

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Emergency medical services providers in 4 different Arizona cities

Inclusion Criteria:

  • Emergency Medical Services personnel at 8 fire departments in AZ who treat patients with out of hospital cardiac arrest (OHCA)

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258244

United States, Arizona
Guardian Medical Transport Recruiting
Flagstaff, Arizona, United States, 86001
Contact: Mark Venuti    928-779-3366    mark.venuti@hahealth.com   
Mesa Fire Department Recruiting
Mesa, Arizona, United States, 85201
Contact: Mary Canelli    480-644-2101    mary.canelli@mesa.gov   
Sponsors and Collaborators
Maricopa Integrated Health System
Arizona Department of Health Services
Guardian Medical Transport
Mesa Fire Department
Zoll Medical Corporation
Principal Investigator: Bentley J Bobrow, MD Arizona Department of Health Services, Maricopa Integrated Health System
More Information

Responsible Party: Maricopa Integrated Health System
ClinicalTrials.gov Identifier: NCT01258244     History of Changes
Other Study ID Numbers: 2010-118
First Posted: December 10, 2010    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015

Keywords provided by Maricopa Integrated Health System:
Out-of-Hospital Cardiac Arrest, OHCA

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases