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Completed

NCT Number: NCT00539539

Automated Real-time Feedback on CPR Study

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.

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Key information

Conditions

Heart Arrest Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Ottawa Hospital, Thunder Bay, Ontario, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laerdal Q-CPR /technology

Other

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 outcomes

  1. Rate of ROSC During the Prehospital Resuscitation

    Time frame: Prehospital resuscitation

    Return of spontaneous circulation (ROSC)

Secondary outcomes

  1. Pulses Present at ED Arrival.

    Time frame: Resuscitation

  2. Survival to Hospital Discharge

    Time frame: Length of Hospitalization

    Survival to hospital discharge

  3. CPR Fraction

    Time frame: Up to 10 minutes of CPR

    Percentage of time during CPR spend doing compressions.

  4. Compression Depth

    Time frame: Up to 10 minutes of CPR

    Average compression depth (mm) during the first 10 minutes of CPR.

  5. Compression Rate

    Time frame: Up to 10 minutes of CPR

    Average compression rate during the first 10 minutes of CPR.

  6. Percentage of Compressions With an Incomplete Release

    Time frame: Up to 10 minutes of CPR

    Percentage of compressions with incomplete release during the first ten minutes of CPR.

  7. Ventilation Rate

    Time frame: Up to 10 minutes of CPR

    Average ventilation rate (breaths/minute) during the first ten minutes of CPR.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Defence Research and Development Canada
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • The Institute of Circulatory and Respiratory Health (ICRH)

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 4, 2007
Registry last updated
Jun 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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