Out of Hospital Cardiac Arrest
Conditions
Keywords
cardiac arrest, cardiopulmonary resuscitation
Brief summary
The primary aim of the trial is to compare survival to hospital discharge after continuous chest compressions (CCC) versus standard American Heart Association (AHA) recommended cardiopulmonary resuscitation (CPR) with interrupted chest compressions (ICC) in patients with out-of-hospital cardiac arrest (OOHCA). The primary null hypothesis will be that the rate of survival to hospital discharge is not affected by use of continuous compressions with passive or positive pressure ventilation (intervention group) versus CPR with compressions interrupted for ventilation at a ratio of 30:2 (control group).
Detailed description
The primary aim of the trial is to compare survival to hospital discharge after continuous chest compressions (CCC) versus standard American Heart Association (AHA) recommended cardiopulmonary resuscitation (CPR) with interrupted chest compressions (ICC) in patients with out-of-hospital cardiac arrest (OOHCA). For this study, CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation followed by rhythm analysis or until restoration of spontaneous circulation (ROSC), whichever occurs first. ICC consists of series of three cycles of standard CPR each cycle comprised of chest compressions with interposed ventilations at a compression:ventilation ratio of 30:2 (per AHA guidelines) followed by rhythm analysis or until ROSC, whichever occurs first. In either patient group, the duration of manual CPR before the first rhythm analysis will be 30 seconds or 120 seconds. This treatment period will be followed by two cycles of compressions then rhythm analysis (i.e. each of approximately 2 minutes duration) in either group. Other aims of the trial are to compare survival to discharge among patients grouped by first-recorded rhythm or other a priori subgroups, as well as to compare neurological status at discharge, mechanistic outcomes or adverse events between control and intervention groups.
Interventions
OTHERStandard CPR
30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first.
OTHERContinuous chest compressions
Continuous chest compressions during the first 6 minutes of the resuscitation.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
American Heart Association
Defence Research and Development Canada
U.S. Army Medical Research and Development Command
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
* Age 18 years or more (or local age of consent); * Initial fire/Emergency Medical Services (EMS) chest compressions provided by Resuscitation Outcomes Consortium (ROC) study participating agency dispatched to the scene; * Lack of the
Exclusion criteria
below
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge | Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first. | Patients may die in the field (outside of the hospital at the time of the cardiac arrest), at the emergency room, in the hospital, or they are discharged alive from the hospital. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Scoring at or Below a 3 on the MRS Scale | Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first. | Neurologic status at discharge will be assessed using the modified Rankin Score (MRS). A higher value indicates a worse outcome. 0-No symptoms at all; 1-No significant disability despite symptoms; able to carry out all usual duties and activities, 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3-Moderate disability; requiring some help, but able to walk without assistance; 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6-Dead |
Countries
Canada, United States
Participant flow
Pre-assignment details
In this cluster randomized crossover trial, there are situations where age and gender are not known prior to the treatment being administered. These missing data account for the discrepancy between the enrollment number in the protocol section (23,711) and those in the participant flow module (23,687).
Participants by arm
| Arm | Count |
|---|---|
| Standard CPR American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations
Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first. | 11,045 |
| Continuous Chest Compressions Continuous compression CPR
Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation. | 12,642 |
| Total | 23,687 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 16 | 34 |
| Overall Study | Withdrawal by Subject | 7 | 5 |
Baseline characteristics
| Characteristic | Standard CPR | Continuous Chest Compressions | Total |
|---|---|---|---|
| Age, Continuous | 66.2 years STANDARD_DEVIATION 17 | 66.4 years STANDARD_DEVIATION 17.2 | 66.3 years STANDARD_DEVIATION 17.1 |
| Gender Female | 3926 Participants | 4618 Participants | 8544 Participants |
| Gender Male | 7119 Participants | 8024 Participants | 15143 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 14 Participants | 12 Participants | 26 Participants |
| Race (NIH/OMB) Asian | 123 Participants | 140 Participants | 263 Participants |
| Race (NIH/OMB) Black or African American | 1246 Participants | 1350 Participants | 2596 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 23 Participants | 28 Participants | 51 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7841 Participants | 9180 Participants | 17021 Participants |
| Race (NIH/OMB) White | 1795 Participants | 1931 Participants | 3726 Participants |
| Region of Enrollment Canada | 6711 participants | 8010 participants | 14721 participants |
| Region of Enrollment United States | 4334 participants | 4632 participants | 8966 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1,197 / 11,045 | 1,310 / 12,642 |
| serious Total, serious adverse events | 0 / 11,045 | 0 / 12,642 |
Outcome results
Primary
Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge
Patients may die in the field (outside of the hospital at the time of the cardiac arrest), at the emergency room, in the hospital, or they are discharged alive from the hospital.
Time frame: Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.
Population: The primary aim of the trial is to compare survival to hospital discharge after continuous chest compressions (CCC) versus standard American Heart Association (AHA) recommended cardiopulmonary resuscitation (CPR) with interrupted chest compressions (ICC) in patients with out-of-hospital cardiac arrest (OOHCA).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard CPR | Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge | 1072 participants |
| Continuous Chest Compressions | Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge | 1127 participants |
Secondary
Percentage of Participants Scoring at or Below a 3 on the MRS Scale
Neurologic status at discharge will be assessed using the modified Rankin Score (MRS). A higher value indicates a worse outcome. 0-No symptoms at all; 1-No significant disability despite symptoms; able to carry out all usual duties and activities, 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3-Moderate disability; requiring some help, but able to walk without assistance; 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6-Dead
Time frame: Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard CPR | Percentage of Participants Scoring at or Below a 3 on the MRS Scale | 7.7 percentage of participants |
| Continuous Chest Compressions | Percentage of Participants Scoring at or Below a 3 on the MRS Scale | 7.0 percentage of participants |