Clinical trial NCT01258244: Arizona Prehospital CPR Quality Improvement Project
Official title: Arizona Prehospital CPR Quality Improvement Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Out-of-Hospital Cardiac Arrest
Keywords: Out-of-Hospital Cardiac Arrest, OHCA
Lead sponsor: Valleywise Health
Sponsor class: OTHER
Collaborators: name: Arizona Department of Health Services
name: Guardian Medical Transport
name: Mesa Fire Department
name: Zoll Medical Corporation
First posted: 2010-12-10
Enrollment: 101
Sex: ALL
Minimum age (years): 24
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency medical services providers in 4 different Arizona cities

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Quality of chest compressions
timeFrame: Phase I - 6 months; Phase II - 20 months
Secondary outcomes:
measure: Survival to hospital discharge
timeFrame: Phase I - 6 months; Phase II - 20 months
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Guardian Medical Transport
state: Arizona
city: Mesa
country: United States
facility: Mesa Fire Department
state: Arizona
Study officials:
affiliation: Arizona Department of Health Services, Maricopa Integrated Health System
name: Bentley J Bobrow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.