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

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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Controlled Study of the Clinical Effectiveness of Automated Real-Time Feedback on CPR Process Conducted at a Subset of ROC Sites

Resource links provided by NLM:

MedlinePlus related topics: Cardiac Arrest

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

Rate of ROSC During the Prehospital Resuscitation [ Time Frame: Prehospital resuscitation ] [ Designated as safety issue: No ]
Return of spontaneous circulation (ROSC)

Secondary Outcome Measures:

Pulses Present at ED Arrival. [ Time Frame: Resuscitation ] [ Designated as safety issue: No ]
Survival to Hospital Discharge [ Time Frame: Length of Hospitalization ] [ Designated as safety issue: No ]
Survival to hospital discharge
CPR Fraction [ Time Frame: Up to 10 minutes of CPR ] [ Designated as safety issue: No ]
Percentage of time during CPR spend doing compressions.
Compression Depth [ Time Frame: Up to 10 minutes of CPR ] [ Designated as safety issue: No ]
Average compression depth (mm) during the first 10 minutes of CPR.
Compression Rate [ Time Frame: Up to 10 minutes of CPR ] [ Designated as safety issue: No ]
Average compression rate during the first 10 minutes of CPR.
Percentage of Compressions With an Incomplete Release [ Time Frame: Up to 10 minutes of CPR ] [ Designated as safety issue: No ]
Percentage of compressions with incomplete release during the first ten minutes of CPR.
Ventilation Rate [ Time Frame: Up to 10 minutes of CPR ] [ Designated as safety issue: No ]
Average ventilation rate (breaths/minute) during the first ten minutes of CPR.

Enrollment:	1586
Study Start Date:	February 2007
Study Completion Date:	September 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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.

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

Locations

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

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:	Susanne May, PhD	University of Washington
Study Director:	Judy Powell, BSN	University of Washington

More Information

Additional Information:

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

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Susanne May, Professor, University of Washington
ClinicalTrials.gov Identifier:	NCT00539539 History of Changes
Other Study ID Numbers:	30707-A, 5U01HL077863-08, 28765
Study First Received:	October 2, 2007
Results First Received:	December 30, 2010
Last Updated:	May 21, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013