Automated Real-time Feedback on CPR Study

University of Washington

Status and phase: Completed; Phase 2

Conditions: Heart Arrest

Treatments: Other: Laerdal Q-CPR /technology

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00539539

30707-A

5U01HL077863-08 (U.S. NIH Grant/Contract)

28765 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,586 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,586 participants in 2 patient groups

Feedback On

Active Comparator group

Description:

Automated real-time feedback on CPR Process activated

Treatment:

Other: Laerdal Q-CPR /technology

Feedback Off

No Intervention group

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.