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Automated Real-time Feedback on CPR Study

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ClinicalTrials.gov Identifier: NCT00539539
Recruitment Status : Completed
First Posted : October 4, 2007
Results First Posted : June 25, 2012
Last Update Posted : June 25, 2012
Sponsor:
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
Information provided by (Responsible Party):
Susanne May, University of Washington

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Heart Arrest Other: Laerdal Q-CPR /technology Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1586 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : February 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : September 2009
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of ROSC During the Prehospital Resuscitation [ Time Frame: Prehospital resuscitation ]
    Return of spontaneous circulation (ROSC)


Secondary Outcome Measures :
  1. Pulses Present at ED Arrival. [ Time Frame: Resuscitation ]
  2. Survival to Hospital Discharge [ Time Frame: Length of Hospitalization ]
    Survival to hospital discharge

  3. CPR Fraction [ Time Frame: Up to 10 minutes of CPR ]
    Percentage of time during CPR spend doing compressions.

  4. Compression Depth [ Time Frame: Up to 10 minutes of CPR ]
    Average compression depth (mm) during the first 10 minutes of CPR.

  5. Compression Rate [ Time Frame: Up to 10 minutes of CPR ]
    Average compression rate during the first 10 minutes of CPR.

  6. Percentage of Compressions With an Incomplete Release [ Time Frame: Up to 10 minutes of CPR ]
    Percentage of compressions with incomplete release during the first ten minutes of CPR.

  7. Ventilation Rate [ Time Frame: Up to 10 minutes of CPR ]
    Average ventilation rate (breaths/minute) during the first ten minutes of CPR.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00539539


Locations
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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
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Principal Investigator: Susanne May, PhD University of Washington
Study Director: Judy Powell, BSN University of Washington
More Information
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Additional Information:

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

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Responsible Party: Susanne May, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00539539    
Other Study ID Numbers: 30707-A
5U01HL077863-08 ( U.S. NIH Grant/Contract )
28765 ( Other Identifier: UW Human Subjects Division )
First Posted: October 4, 2007    Key Record Dates
Results First Posted: June 25, 2012
Last Update Posted: June 25, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases