Arizona Prehospital CPR Quality Improvement Project

Out-of-Hospital Cardiac Arrest Clinical Trial

Official title:

Arizona Prehospital CPR Quality Improvement Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258244
• Other study ID #: 2010-118
• Status: Completed
• Phase: N/A
• First received: December 9, 2010
• Last updated: January 22, 2018
• Start date: December 7, 2010
• Est. completion date: February 25, 2015

Study information

• Verified date: January 2018
• Source: Maricopa Integrated Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 25, 2015
• Est. primary completion date: February 25, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years to 55 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Other:
• Audiovisual Feedback
EMTs will get audiovisual feedback on CPR technique during CPR

Locations

Country	Name	City	State
United States	Guardian Medical Transport	Flagstaff	Arizona
United States	Mesa Fire Department	Mesa	Arizona

Sponsors (5)

Lead Sponsor	Collaborator
Maricopa Integrated Health System	Arizona Department of Health Services, Guardian Medical Transport, Mesa Fire Department, Zoll Medical Corporation

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of chest compressions	Depth of chest compressions, rate of chest compressions, and interruptions in chest compressions	Phase I - 6 months; Phase II - 20 months
Secondary	Survival to hospital discharge	Did the patient survive to hospital discharge? (Yes or no--dichotomous measure)	Phase I - 6 months; Phase II - 20 months