Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5U01HL077863-08 | U.S. NIH Grant/Contract | View source | |
| 28765 | Other Identifier | UW Human Subjects Division |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| The Institute of Circulatory and Respiratory Health (ICRH) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feedback On | Active Comparator | Automated real-time feedback on CPR Process activated |
|
| Feedback Off | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of ROSC During the Prehospital Resuscitation | Return of spontaneous circulation (ROSC) | Prehospital resuscitation |
| Measure | Description | Time Frame |
|---|---|---|
| Pulses Present at ED Arrival. | Resuscitation | |
| Survival to Hospital Discharge | Survival to hospital discharge | Length of Hospitalization |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susanne May, PhD | University of Washington | Principal Investigator |
| Judy Powell, BSN | University of Washington | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States | ||
| University of Washington |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21296838 | Derived | Hostler D, Everson-Stewart S, Rea TD, Stiell IG, Callaway CW, Kudenchuk PJ, Sears GK, Emerson SS, Nichol G; Resuscitation Outcomes Consortium Investigators. Effect of real-time feedback during cardiopulmonary resuscitation outside hospital: prospective, cluster-randomised trial. BMJ. 2011 Feb 4;342:d512. doi: 10.1136/bmj.d512. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Feedback On | Automated real-time feedback on CPR Process activated |
| FG001 | Feedback Off | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Feedback On | Automated real-time feedback on CPR Process activated |
| BG001 | Feedback Off | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Categorical | Age is available on 1171 participants; 585 on feedback on arm; 586 on the feedback off arm |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of ROSC During the Prehospital Resuscitation | Return of spontaneous circulation (ROSC) | Intent to treat | Posted | Number | Participants | Prehospital resuscitation |
|
Pre-hospital resuscitation and hospitalization.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Feedback On | Automated real-time feedback on CPR Process activated |
Not provided
Not provided
Open label study - providers not blinded to intervention. High rates of missing CPR process measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susanne May, Ph.D. | Resusciatation Outcomes Consortium, University of Washington | 206-685-1302 | sjmay@uw.edu |
Not provided
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013672 | Technology |
| ID | Term |
|---|---|
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided
| Defence Research and Development Canada | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| Seattle |
| Washington |
| 98199 |
| United States |
| The Ottawa Hospital | Thunder Bay | Ontario | K1Y 4E9 | Canada |
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Age Continuous | Age available for 1171 participants; 585 on feedback arm; 586 on feedback off arm | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Pulses Present at ED Arrival. | Intention to treat. Presence of pulses not known for one participant on the feedback off arm. Analysis includes 815 participants on the feedback on arm and 770 on the feedback off arm. | Posted | Number | Participants | Resuscitation |
|
|
|
|
| Secondary | Survival to Hospital Discharge | Survival to hospital discharge | Intention to treat, with survival to hospital discharge missing for one participant on the feedback off arm. Analysis included 815 participants on the feedback on arm, and 770 on the feedback off arm. | Posted | Sep 2010 | Number | Participants | Length of Hospitalization |
|
|
|
|
| Secondary | CPR Fraction | Percentage of time during CPR spend doing compressions. | Intention to treat, with CPR fraction available for 604 participants on the feedback on arm, and 570 on the feedback off arm. | Posted | Mean | Standard Error | Percentage | Up to 10 minutes of CPR |
|
|
|
|
| Secondary | Compression Depth | Average compression depth (mm) during the first 10 minutes of CPR. | Intention to treat. Compression depth available for 529 participants on the feedback on arm and 467 on the feedback off arm. | Posted | Mean | Standard Error | mm | Up to 10 minutes of CPR |
|
|
|
|
| Secondary | Compression Rate | Average compression rate during the first 10 minutes of CPR. | Intention to treat. Average compression rate available for 604 participants on the feedback on arm and 570 on the feedback off arm. | Posted | Mean | Standard Error | Compressions per minute | Up to 10 minutes of CPR |
|
|
|
|
| Secondary | Percentage of Compressions With an Incomplete Release | Percentage of compressions with incomplete release during the first ten minutes of CPR. | Intention to treat. Incomplete release available for 529 participants on the feedback on arm and 467 on the feedback off arm. | Posted | Mean | Standard Error | % of compressions w/ incomplete release | Up to 10 minutes of CPR |
|
|
|
|
| Secondary | Ventilation Rate | Average ventilation rate (breaths/minute) during the first ten minutes of CPR. | Intention to treat. Ventilation rate available in 347 participants on the feedback on arm and 346 on the feedback off arm. | Posted | Mean | Standard Error | breaths per minute | Up to 10 minutes of CPR |
|
|
|
|
| 0 |
| 815 |
| 0 |
| 815 |
| EG001 | Feedback Off | 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. | 0 | 771 | 0 | 771 |
Not provided
Not provided