Heart Arrest
Conditions
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.
Interventions
OTHERLaerdal 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
The Institute of Circulatory and Respiratory Health (ICRH)
Defence Research and Development Canada
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of ROSC During the Prehospital Resuscitation | Prehospital resuscitation | Return of spontaneous circulation (ROSC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Pulses Present at ED Arrival. | Resuscitation | — |
| 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. |
| Ventilation Rate | Up to 10 minutes of CPR | Average ventilation rate (breaths/minute) during the first ten minutes of CPR. |
| Compression Rate | Up to 10 minutes of CPR | Average compression rate during the first 10 minutes of CPR. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Feedback On Automated real-time feedback on CPR Process activated | 815 |
| 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. | 771 |
| Total | 1,586 |
Baseline characteristics
| Characteristic | Feedback On | Feedback Off | Total |
|---|---|---|---|
| Age Categorical <=18 years | 0 participants | 0 participants | 0 participants |
| Age Categorical >=65 years | 310 participants | 298 participants | 608 participants |
| Age Categorical Between 18 and 65 years | 275 participants | 288 participants | 563 participants |
| Age Continuous | 65 years STANDARD_DEVIATION 17 | 66 years STANDARD_DEVIATION 17 | 66 years STANDARD_DEVIATION 17 |
| Region of Enrollment Canada | 38 participants | 5 participants | 43 participants |
| Region of Enrollment United States | 777 participants | 766 participants | 1543 participants |
| Sex: Female, Male Female | 295 Participants | 291 Participants | 586 Participants |
| Sex: Female, Male Male | 520 Participants | 480 Participants | 1000 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 815 | 0 / 771 |
| serious Total, serious adverse events | 0 / 815 | 0 / 771 |
Outcome results
Primary
Rate of ROSC During the Prehospital Resuscitation
Return of spontaneous circulation (ROSC)
Time frame: Prehospital resuscitation
Population: Intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Feedback On | Rate of ROSC During the Prehospital Resuscitation | 361 Participants |
| Feedback Off | Rate of ROSC During the Prehospital Resuscitation | 345 Participants |
Comparison: Average change in cluster-specific rates of ROSC.p-value: 0.9695% CI: [-0.04, 0.05]t-test, 2 sided
Secondary
Compression Depth
Average compression depth (mm) during the first 10 minutes of CPR.
Time frame: Up to 10 minutes of CPR
Population: Intention to treat. Compression depth available for 529 participants on the feedback on arm and 467 on the feedback off arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feedback On | Compression Depth | 39.6 mm | Standard Error 0.4 |
| Feedback Off | Compression Depth | 37.8 mm | Standard Error 0.4 |
Comparison: Cluster adjusted difference in means.p-value: 0.00595% CI: [0.5, 2.7]Regression, Linear
Secondary
Compression Rate
Average compression rate during the first 10 minutes of CPR.
Time frame: Up to 10 minutes of CPR
Population: Intention to treat. Average compression rate available for 604 participants on the feedback on arm and 570 on the feedback off arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feedback On | Compression Rate | 103.1 Compressions per minute | Standard Error 0.5 |
| Feedback Off | Compression Rate | 108.0 Compressions per minute | Standard Error 0.7 |
Comparison: Cluster adjusted difference in average compression rate.p-value: <0.00195% CI: [-6.4, -3]Regression, Linear
Secondary
CPR Fraction
Percentage of time during CPR spend doing compressions.
Time frame: Up to 10 minutes of CPR
Population: Intention to treat, with CPR fraction available for 604 participants on the feedback on arm, and 570 on the feedback off arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feedback On | CPR Fraction | 66 Percentage | Standard Error 1 |
| Feedback Off | CPR Fraction | 64 Percentage | Standard Error 1 |
Comparison: Cluster adjusted difference in average CPR fraction.p-value: 0.01695% CI: [0.4, 3.4]Regression, Linear
Secondary
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
Population: Intention to treat. Incomplete release available for 529 participants on the feedback on arm and 467 on the feedback off arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feedback On | Percentage of Compressions With an Incomplete Release | 10.4 % of compressions w/ incomplete release | Standard Error 1 |
| Feedback Off | Percentage of Compressions With an Incomplete Release | 14.6 % of compressions w/ incomplete release | Standard Error 1 |
Comparison: Cluster adjusted difference in the average rate.p-value: <0.00195% CI: [-5.2, -1.5]Regression, Linear
Secondary
Pulses Present at ED Arrival.
Time frame: Resuscitation
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Feedback On | Pulses Present at ED Arrival. | 260 Participants |
| Feedback Off | Pulses Present at ED Arrival. | 243 Participants |
Comparison: Average difference in cluster-specific rates.p-value: 0.7195% CI: [-4.9, 3.4]t-test, 2 sided
Secondary
Survival to Hospital Discharge
Survival to hospital discharge
Time frame: Length of Hospitalization
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Feedback On | Survival to Hospital Discharge | 92 Participants |
| Feedback Off | Survival to Hospital Discharge | 96 Participants |
Comparison: Average change in cluster-specific risk difference.p-value: 0.2195% CI: [-0.039, 0.009]t-test, 2 sided
Secondary
Ventilation Rate
Average ventilation rate (breaths/minute) during the first ten minutes of CPR.
Time frame: Up to 10 minutes of CPR
Population: Intention to treat. Ventilation rate available in 347 participants on the feedback on arm and 346 on the feedback off arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feedback On | Ventilation Rate | 5.8 breaths per minute | Standard Error 0.2 |
| Feedback Off | Ventilation Rate | 5.6 breaths per minute | Standard Error 0.2 |
Comparison: Cluster adjusted difference in average rate.p-value: 0.7395% CI: [-0.5, 0.7]Regression, Linear