Automated Real-time Feedback on CPR Study

This study has been completed.
Sponsor:
Collaborators:
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
  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:


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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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:
No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 14, 2014