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Automated Real-time Feedback on CPR Study

Primary Purpose

Heart Arrest

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Laerdal Q-CPR /technology
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh
  • University of Washington
  • The Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Feedback On

Feedback Off

Arm Description

Automated real-time feedback on CPR Process activated

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.

Outcomes

Primary Outcome Measures

Rate of ROSC During the Prehospital Resuscitation
Return of spontaneous circulation (ROSC)

Secondary Outcome Measures

Pulses Present at ED Arrival.
Survival to Hospital Discharge
Survival to hospital discharge
CPR Fraction
Percentage of time during CPR spend doing compressions.
Compression Depth
Average compression depth (mm) during the first 10 minutes of CPR.
Compression Rate
Average compression rate during the first 10 minutes of CPR.
Percentage of Compressions With an Incomplete Release
Percentage of compressions with incomplete release during the first ten minutes of CPR.
Ventilation Rate
Average ventilation rate (breaths/minute) during the first ten minutes of CPR.

Full Information

First Posted
October 2, 2007
Last Updated
May 21, 2012
Sponsor
University of Washington
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
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1. Study Identification

Unique Protocol Identification Number
NCT00539539
Brief Title
Automated Real-time Feedback on CPR Study
Official Title
Controlled Study of the Clinical Effectiveness of Automated Real-Time Feedback on CPR Process Conducted at a Subset of ROC Sites
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1586 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Feedback On
Arm Type
Active Comparator
Arm Description
Automated real-time feedback on CPR Process activated
Arm Title
Feedback Off
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Laerdal Q-CPR /technology
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of ROSC During the Prehospital Resuscitation
Description
Return of spontaneous circulation (ROSC)
Time Frame
Prehospital resuscitation
Secondary Outcome Measure Information:
Title
Pulses Present at ED Arrival.
Time Frame
Resuscitation
Title
Survival to Hospital Discharge
Description
Survival to hospital discharge
Time Frame
Length of Hospitalization
Title
CPR Fraction
Description
Percentage of time during CPR spend doing compressions.
Time Frame
Up to 10 minutes of CPR
Title
Compression Depth
Description
Average compression depth (mm) during the first 10 minutes of CPR.
Time Frame
Up to 10 minutes of CPR
Title
Compression Rate
Description
Average compression rate during the first 10 minutes of CPR.
Time Frame
Up to 10 minutes of CPR
Title
Percentage of Compressions With an Incomplete Release
Description
Percentage of compressions with incomplete release during the first ten minutes of CPR.
Time Frame
Up to 10 minutes of CPR
Title
Ventilation Rate
Description
Average ventilation rate (breaths/minute) during the first ten minutes of CPR.
Time Frame
Up to 10 minutes of CPR

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne May, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Judy Powell, BSN
Organizational Affiliation
University of Washington
Official's Role
Study Director
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98199
Country
United States
Facility Name
The Ottawa Hospital
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21296838
Citation
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. doi: 10.1136/bmj.d512.
Results Reference
derived
Links:
URL
https://www.uwctc.org/
Description
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