Automated Real-time Feedback on CPR Study

Controlled Study of the Clinical Effectiveness of Automated Real-Time Feedback on CPR Process Conducted at a Subset of ROC Sites

The purpose of this study is to evaluate whether or not real-time feedback on CPR process variables will increase rates of restoration of spontaneous circulation during prehospital resuscitation and upon arrival at the receiving emergency room as well as increase rates of survival to hospital discharge.

Study Overview

• Status: Completed
• Conditions: Heart Arrest
• Intervention / Treatment: Other: Laerdal Q-CPR /technology

Detailed Description

A subset of emergency medical services (EMS) agencies that are participating in the Resuscitation Outcomes Consortium (ROC) are adopting new monitor/defibrillators that are capable of monitoring CPR process during attempted resuscitation of patients in cardiac arrest, as well as providing automated real-time feedback about this process to EMS providers so as to improve compliance with recommended guidelines for CPR. Monitoring of CPR process during attempted resuscitation is an important step towards reducing the potential for poorly-performed CPR to modify the effect of the study interventions upon outcome. Clusters formed of rigs, an individual agency or groups of agencies were randomized to turn feedback on or off. After a fixed period of time, each cluster crossed over to the other arm. An unequal number of subjects were enrolled during each period.

• Study Type: Interventional
• Enrollment (Actual): 1586
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Thunder Bay, Ontario, Canada, K1Y 4E9
      • The Ottawa Hospital
• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • Washington
    • Seattle, Washington, United States, 98199
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all individuals who experience cardiac arrest outside the hospital,
• are evaluated by organized EMS personnel and: a) receive attempts at external defibrillation (by lay responders or emergency personnel) or receive chest compressions by organized EMS personnel.

Exclusion Criteria:

• Use of a mechanical CPR device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Feedback On; Automated real-time feedback on CPR Process activated	Other: Laerdal Q-CPR /technology; For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
No Intervention: Feedback Off; For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of ROSC During the Prehospital Resuscitation	Return of spontaneous circulation (ROSC)	Prehospital resuscitation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulses Present at ED Arrival.		Resuscitation
Survival to Hospital Discharge	Survival to hospital discharge	Length of Hospitalization
CPR Fraction	Percentage of time during CPR spend doing compressions.	Up to 10 minutes of CPR
Compression Depth	Average compression depth (mm) during the first 10 minutes of CPR.	Up to 10 minutes of CPR
Compression Rate	Average compression rate during the first 10 minutes of CPR.	Up to 10 minutes of CPR
Percentage of Compressions With an Incomplete Release	Percentage of compressions with incomplete release during the first ten minutes of CPR.	Up to 10 minutes of CPR
Ventilation Rate	Average ventilation rate (breaths/minute) during the first ten minutes of CPR.	Up to 10 minutes of CPR

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institute of Neurological Disorders and Stroke (NINDS); The Institute of Circulatory and Respiratory Health (ICRH); Defence Research and Development Canada
• Investigators: Principal Investigator: Susanne May, PhD, University of Washington; Study Director: Judy Powell, BSN, University of Washington

Publications and helpful links

General Publications

• Hostler D, Everson-Stewart S, Rea TD, Stiell IG, Callaway CW, Kudenchuk PJ, Sears GK, Emerson SS, Nichol G; Resuscitation Outcomes Consortium Investigators. Effect of real-time feedback during cardiopulmonary resuscitation outside hospital: prospective, cluster-randomised trial. BMJ. 2011 Feb 4;342:d512. doi: 10.1136/bmj.d512.

Helpful Links

• Click here for more information about this study: CPR Feedback Study

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: October 2, 2007
• First Submitted That Met QC Criteria: October 3, 2007
• First Posted (Estimate): October 4, 2007

Study Record Updates

• Last Update Posted (Estimate): June 25, 2012
• Last Update Submitted That Met QC Criteria: May 21, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: 30707-A; 5U01HL077863-08 (U.S. NIH Grant/Contract); 28765 (Other Identifier: UW Human Subjects Division)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No