Automated Real-time Feedback on CPR Study

Phase 2

Completed

• Conditions: Heart Arrest
• Interventions: Other: Laerdal Q-CPR /technology

• Registration Number: NCT00539539
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-10-02
• Study First Submitted QC: 2007-10-03
• Study First Posted: 2007-10-04
• Primary Completion: 2009-06
• Study Completion: 2009-09
• Results First Submitted: 2010-12-30
• Status Verified: 2012-05
• Results First Submitted QC: 2012-05-21
• Last Update Submitted: 2012-05-21
• Results First Posted: 2012-06-25
• Last Update Posted: 2012-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1586

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.

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Exclusion Criteria

• Use of a mechanical CPR device

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Feedback On	Laerdal Q-CPR /technology	Automated real-time feedback on CPR Process activated

Primary Outcome Measures

Name	Time	Method
Rate of ROSC During the Prehospital Resuscitation	Prehospital resuscitation	Return of spontaneous circulation (ROSC)

Secondary Outcome Measures

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

Trial Locations

Locations (3)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

The Ottawa Hospital; 🇨🇦 Thunder Bay, Ontario, Canada