Cardiac Arrest, Cardiopulmonary Resuscitation
Conditions
Keywords
CPR, mechanical, manual, outcome, survival, quality
Brief summary
During resuscitation of out of hospital cardiac arrest patients the use of a mechanical chest compression device Autopulse will improve survival compared to manual compressions.
Detailed description
Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. Several studies document sub optimal quality of manual chest compressions and this may influence outcome. However, studies comparing manual and mechanical chest compressions have resulted in conflicted results. The investigators think this may be based on methodology and design issues of the trials as much as not focusing on training and experience in operating a mechanical device clinically. Therefore the investigators will focus on these issues and implement three phases in the study (In field training, Run In phase, and Study phase). The investigators will also focus on early use of mechanical CPR after arrival at patient side and randomization at arrival. In order to achieve this the investigators will follow the Norwegian CPR Guidelines with 3 min CPR before defibrillation and the 3 min algorithm. Quality of CPR will be monitored.
Interventions
Sponsors
Ullevaal University Hospital
Zoll Medical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patents aged 18 years (or local age of consent) or more who suffer non-traumatic arrest of presumed cardiac etiology in an out-of-hospital setting and who do not meet any of the
Exclusion criteria
below.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Discharge | From time of first contact until hospital discharge, up to 90 days. | Whether a subject was discharged alive from the hospital or alternatively died prior to discharge. |
Countries
Austria, Netherlands, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| iA-CPR Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.
AutoPulse: Mechanical device that provides chest compression | 2,099 |
| M-CPR Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.
Manual: Manual chest compression | 2,132 |
| Total | 4,231 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 7 |
Baseline characteristics
| Characteristic | iA-CPR | M-CPR | Total |
|---|---|---|---|
| Age, Customized 18-59 years | 706 participants | 734 participants | 1440 participants |
| Age, Customized 60-74 years | 671 participants | 689 participants | 1360 participants |
| Age, Customized 75+ years | 722 participants | 709 participants | 1431 participants |
| Sex: Female, Male Female | 784 Participants | 837 Participants | 1621 Participants |
| Sex: Female, Male Male | 1315 Participants | 1295 Participants | 2610 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 242 / 2,099 | 225 / 2,132 |
| serious Total, serious adverse events | 11 / 2,099 | 1 / 2,132 |
Outcome results
Primary
Hospital Discharge
Whether a subject was discharged alive from the hospital or alternatively died prior to discharge.
Time frame: From time of first contact until hospital discharge, up to 90 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| iA-CPR | Hospital Discharge | 196 participants |
| M-CPR | Hospital Discharge | 233 participants |