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Automated Real-time Feedback on CPR Study

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00539539
First received: October 2, 2007
Last updated: May 21, 2012
Last verified: May 2012
History of Changes
Results First Received: December 30, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Heart Arrest
Intervention: Other: Laerdal Q-CPR /technology

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Feedback On Automated real-time feedback on CPR Process activated
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.

Participant Flow:   Overall Study
    Feedback On     Feedback Off  
STARTED     815     771  
COMPLETED     815     771  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Feedback On Automated real-time feedback on CPR Process activated
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.
Total Total of all reporting groups

Baseline Measures
    Feedback On     Feedback Off     Total  
Number of Participants  
[units: participants]
 		  815     771     1586  
Age [1]
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     275     288     563  
>=65 years     310     298     608  
Age [2]
[units: years]
Mean ± Standard Deviation 		  65  ± 17     66  ± 17     66  ± 17  
Gender  
[units: participants]
 		     
Female     295     291     586  
Male     520     480     1000  
Region of Enrollment  
[units: participants]
 		     
United States     777     766     1543  
Canada     38     5     43  
[1] Age is available on 1171 participants; 585 on feedback on arm; 586 on the feedback off arm
[2] Age available for 1171 participants; 585 on feedback arm; 586 on feedback off arm



  Outcome Measures
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1.  Primary:   Rate of ROSC During the Prehospital Resuscitation   [ Time Frame: Prehospital resuscitation ]
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2.  Secondary:   Pulses Present at ED Arrival.   [ Time Frame: Resuscitation ]
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3.  Secondary:   Survival to Hospital Discharge   [ Time Frame: Length of Hospitalization ]
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4.  Secondary:   CPR Fraction   [ Time Frame: Up to 10 minutes of CPR ]
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5.  Secondary:   Compression Depth   [ Time Frame: Up to 10 minutes of CPR ]
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6.  Secondary:   Compression Rate   [ Time Frame: Up to 10 minutes of CPR ]
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7.  Secondary:   Percentage of Compressions With an Incomplete Release   [ Time Frame: Up to 10 minutes of CPR ]
  Show Outcome Measure 7

8.  Secondary:   Ventilation Rate   [ Time Frame: Up to 10 minutes of CPR ]
  Show Outcome Measure 8


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Open label study - providers not blinded to intervention. High rates of missing CPR process measures.  


Results Point of Contact:  
Name/Title: Susanne May, Ph.D.
Organization: Resusciatation Outcomes Consortium, University of Washington
phone: 206-685-1302
e-mail: sjmay@uw.edu


No publications provided by University of Washington

Publications automatically indexed to this study:


Responsible Party: Susanne May, 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