Automated Real-time Feedback on CPR Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Controlled Study of the Clinical Effectiveness of Automated Real-Time Feedback on CPR Process Conducted at a Subset of ROC Sites

Conditions
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Heart Arrest

Intervention / Treatment
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* Other: Laerdal Q-CPR /technology


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Feedback On<br>Automated real-time feedback on CPR Process activated | Other: Laerdal Q-CPR /technology<br>* 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.<br>|
| No Intervention: Feedback Off<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ROSC During the Prehospital Resuscitation | Return of spontaneous circulation (ROSC) | Prehospital resuscitation | 

Secondary Outcome Measures

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