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| Name | Class |
|---|---|
| Ullevaal University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Mechanical CPR with AutoPulse |
|
| 2 | Other | Manual CPR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AutoPulse | Device | Mechanical device that provides chest compression |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Discharge | Whether a subject was discharged alive from the hospital or alternatively died prior to discharge. | From time of first contact until hospital discharge, up to 90 days. |
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Inclusion Criteria:
Exclusion Criteria:
Traumatic arrest (blunt, penetrating, burns)
Arrest due to exsanguinations, strangulation, smoke inhalation, drug overdose, electrocution, hanging, drowning.
Known or clinically apparent pregnancy
Do Not Attempt to Resuscitate (DNAR) orders
Apparent patient weight more than 225 kg (500 lbs)
Wards of the state
Prisoner
CPR device other than AutoPulse
Patients who are reached after 16 minutes after the time of emergency call (911). This exclusion is determined at the time of CRF abstraction, not during treatment of the patient.
If patient is unaccompanied, or accompanied by a person or persons unfamiliar with their his-tory, determination of these exclusion criteria will, perforce, be left to the best estimation of the rescue personnel. At no time, should an attempt to determine these criteria be allowed to delay the administration of life-saving treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Lars Wik, MD | Ullevaal University Hospital | Principal Investigator |
| David Persse, MD | Houston Fire | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hillsborough Fire Rescue | Tampa | Florida | 33610 | United States | ||
| Houston Fire |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30708074 | Derived | Olsen JA, Brunborg C, Steinberg M, Persse D, Sterz F, Lozano M Jr, Westfall M, van Grunsven PM, Lerner EB, Wik L. Survival to hospital discharge with biphasic fixed 360 joules versus 200 escalating to 360 joules defibrillation strategies in out-of-hospital cardiac arrest of presumed cardiac etiology. Resuscitation. 2019 Mar;136:112-118. doi: 10.1016/j.resuscitation.2019.01.020. Epub 2019 Jan 29. | |
| 27155547 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Hospital Discharge | Whether a subject was discharged alive from the hospital or alternatively died prior to discharge. | Posted | Number | participants | From time of first contact until hospital discharge, up to 90 days. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CPR related injuries | Injury, poisoning and procedural complications | Non-systematic Assessment | CPR related injuries exceeding the normally expected seriousness |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director of Clinical Research | ZOLL Medical Corporation | 978-421-9655 | uherken@zoll.com |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Manual |
| Other |
Manual chest compression |
|
| Houston |
| Texas |
| 77002 |
| United States |
| Gold Cross EMS | Menasha | Wisconsin | 54952 | United States |
| Vienna EMS | Vienna | Austria |
| Nijmegen EMS | Nijmegen | Netherlands |
| Derived |
| Wik L, Olsen JA, Persse D, Sterz F, Lozano M Jr, Brouwer MA, Westfall M, Souders CM, Travis DT, Herken UR, Lerner EB. Why do some studies find that CPR fraction is not a predictor of survival? Resuscitation. 2016 Jul;104:59-62. doi: 10.1016/j.resuscitation.2016.04.013. Epub 2016 May 4. |
| 25461493 | Derived | Steinberg MT, Olsen JA, Brunborg C, Persse D, Sterz F, Lozano M Jr, Brouwer MA, Westfall M, Souders CM, van Grunsven PM, Travis DT, Lerner EB, Wik L. Minimizing pre-shock chest compression pauses in a cardiopulmonary resuscitation cycle by performing an earlier rhythm analysis. Resuscitation. 2015 Feb;87:33-7. doi: 10.1016/j.resuscitation.2014.11.012. Epub 2014 Nov 21. |
| 24642406 | Derived | Wik L, Olsen JA, Persse D, Sterz F, Lozano M Jr, Brouwer MA, Westfall M, Souders CM, Malzer R, van Grunsven PM, Travis DT, Whitehead A, Herken UR, Lerner EB. Manual vs. integrated automatic load-distributing band CPR with equal survival after out of hospital cardiac arrest. The randomized CIRC trial. Resuscitation. 2014 Jun;85(6):741-8. doi: 10.1016/j.resuscitation.2014.03.005. Epub 2014 Mar 15. |
| 21196070 | Derived | Lerner EB, Persse D, Souders CM, Sterz F, Malzer R, Lozano M Jr, Westfall M, Brouwer MA, van Grunsven PM, Whitehead A, Olsen JA, Herken UR, Wik L. Design of the Circulation Improving Resuscitation Care (CIRC) Trial: a new state of the art design for out-of-hospital cardiac arrest research. Resuscitation. 2011 Mar;82(3):294-9. doi: 10.1016/j.resuscitation.2010.11.013. Epub 2010 Dec 31. |
| 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 |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 11 |
| 2,099 |
| 242 |
| 2,099 |
| EG001 | 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 | 1 | 2,132 | 225 | 2,132 |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rib Fractures | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Subcutaneous emphysema | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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