Automated Real-Time Feedback on CPR Study - Full Text View

Sponsors and Collaborators:	University of Washington 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
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00539539

Purpose

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.

Condition	Intervention	Phase
Heart Arrest	Other: Laerdal Q-CPR /technology	Phase III

Drug Information available for: BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Official Title:	Controlled Study of the Clinical Effectiveness of Automated Real-Time Feedback on CPR Process Conducted at a Subset of ROC Sites

Further study details as provided by University of Washington:

Primary Outcome Measures:

Rate of ROSC during the prehospital resuscitation [ Time Frame: Fifteen months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The presence of spontaneous circulation upon arrival at the hospital, survival to hospital discharge, and adherence to guidelines for CPR fraction, rate and depth of chest compression, complete release of compression, and rate of ventilation. [ Time Frame: Fifteen months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1554
Study Start Date:	February 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: No Intervention 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.

Arms

Assigned Interventions

1: Active Comparator

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.

2: No Intervention

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539539

Contacts

Contact: Amy Gest

(206) 616-0414

agest@u.washington.edu

Locations

United States, Pennsylvania
University of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Clifton W Callaway, MD, PhD 412-647-9047 callawaycw@upmc.edu
Contact: David Hostler, PhD (412) 6473078 hostlerdp@upmc.edu
Principal Investigator: Clifton W Callaway, MD, PhD
United States, Washington
University of Washington	Recruiting
Seattle, Washington, United States, 98199
Contact: Peter Kudenchuk, MD 206-685-4176 kudenchu@u.washington.edu
Contact: Tom Rea, MD 206) 296-4693 Rea123@u.washington.edu
Principal Investigator: Peter Kudenchuk, MD
Canada, Ontario
The Ottawa Hospital	Recruiting
Thunder Bay, Ontario, Canada, K1Y 4E9
Contact: Ian Stiell, MD 613) 798-5555 ext 18683 istiell@ohri.ca
Contact: Cathy Clement, RN (613) 798-5555 ext 16615 cclement@ohri.ca
Principal Investigator: Ian Stiell, MD

Sponsors and Collaborators

University of Washington

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:	Scott Emerson, MD, PhD	University of Washington
Study Director:	Judy Powell, BSN	University of Washington

More Information

Click here for more information about this study: CPR Feedback Study This link exits the ClinicalTrials.gov site

Responsible Party:	University of Washington ( Scott Emerson, MD, PhD )
Study ID Numbers:	06-3100-A01, 91-6001537
Study First Received:	October 2, 2007
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00539539
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Heart Diseases
Heart Arrest

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009