A Phase 2 interventional study of Laerdal Q-CPR /technology in Heart Arrest, sponsored by University of Washington. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-25.
Sponsored by University of Washington · Phase 2, Interventional, and Treatment
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.
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.
966 studies on the registry are indexed under Heart Arrest; 226 are open to participants now.
This study's enrollment of 1,586 is above the median of 100 across 557 interventional studies indexed under Heart Arrest.
Browse Heart Arrest studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Automated real-time feedback on CPR Process activated
Other: Laerdal Q-CPR /technology
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.
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.
Rate of ROSC During the Prehospital Resuscitation
Return of spontaneous circulation (ROSC)
Time frame: Prehospital resuscitation
Pulses Present at ED Arrival.
Time frame: Resuscitation
Survival to Hospital Discharge
Survival to hospital discharge
Time frame: Length of Hospitalization
CPR Fraction
Percentage of time during CPR spend doing compressions.
Time frame: Up to 10 minutes of CPR
Compression Depth
Average compression depth (mm) during the first 10 minutes of CPR.
Time frame: Up to 10 minutes of CPR
Compression Rate
Average compression rate during the first 10 minutes of CPR.
Time frame: 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.
Time frame: Up to 10 minutes of CPR
Ventilation Rate
Average ventilation rate (breaths/minute) during the first ten minutes of CPR.
Time frame: Up to 10 minutes of CPR
| Milestone | Feedback On | Feedback Off |
|---|---|---|
| Started | 815 | 771 |
| Completed | 815 | 771 |
| Not completed | 0 | 0 |
Return of spontaneous circulation (ROSC)
| Participants | Feedback On | Feedback Off |
|---|---|---|
| Rate of ROSC During the Prehospital Resuscitation | 361 | 345 |
| Participants | Feedback On | Feedback Off |
|---|---|---|
| Pulses Present at ED Arrival. | 260 | 243 |
Survival to hospital discharge
| Participants | Feedback On | Feedback Off |
|---|---|---|
| Survival to Hospital Discharge | 92 | 96 |
Percentage of time during CPR spend doing compressions.
| Percentage | Feedback On | Feedback Off |
|---|---|---|
| CPR Fraction | 66 ± 1 | 64 ± 1 |
Average compression depth (mm) during the first 10 minutes of CPR.
| mm | Feedback On | Feedback Off |
|---|---|---|
| Compression Depth | 39.6 ± 0.4 | 37.8 ± 0.4 |
Average compression rate during the first 10 minutes of CPR.
| Compressions per minute | Feedback On | Feedback Off |
|---|---|---|
| Compression Rate | 103.1 ± 0.5 | 108.0 ± 0.7 |
Percentage of compressions with incomplete release during the first ten minutes of CPR.
| % of compressions w/ incomplete release | Feedback On | Feedback Off |
|---|---|---|
| Percentage of Compressions With an Incomplete Release | 10.4 ± 1 | 14.6 ± 1 |
Average ventilation rate (breaths/minute) during the first ten minutes of CPR.
| breaths per minute | Feedback On | Feedback Off |
|---|---|---|
| Ventilation Rate | 5.8 ± 0.2 | 5.6 ± 0.2 |
Collected over Pre-hospital resuscitation and hospitalization.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Feedback On | — | 0/815 (0%) | 0/815 (0%) |
| Feedback Off | — | 0/771 (0%) | 0/771 (0%) |
| Age Categorical(participants) | Feedback On | Feedback Off | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 275 | 288 | 563 |
| >=65 years | 310 | 298 | 608 |
| Age Continuous(years) | Feedback On | Feedback Off | Total |
|---|---|---|---|
| Mean | 65 ± 17 | 66 ± 17 | 66 ± 17 |
| Sex: Female, Male(Participants) | Feedback On | Feedback Off | Total |
|---|---|---|---|
| Female | 295 | 291 | 586 |
| Male | 520 | 480 | 1000 |
| Region of Enrollment(participants) | Feedback On | Feedback Off | Total |
|---|---|---|---|
| United States | 777 | 766 | 1543 |
| Canada | 38 | 5 | 43 |
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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