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This study will compare the effect of constant low-level energy [150 joules] to an escalating energy [200-300-360 joules] regimen of biphasic waveform defibrillation on multiple patient outcomes.
This pilot, which will enroll 200 subjects, will allow a reasonable estimate of effect size and this will, in turn, allow for the accurate design and planning of a definitive randomized controlled trial. The following outcomes will be evaluated:
Important Clinical Outcomes:
Process Outcomes:
Adverse Outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed lower-energy | Active Comparator | Out-of-hospital cardiac arrest patients undergoing defibrillation received a fixed lower-energy regimen of 150 J for all shocks |
|
| Escalating higher-Energy | Active Comparator | Out-of-hospital cardiac arrest patients undergoing defibrillation received an escalating higher-energy regimen beginning with 200 J, proceeding to 300 J for the second shock and 360 J for all remaining shocks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed lower-energy defibrillation | Procedure | Every shock administered at 150 J |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Conversion to an Organized Heart Rhythm | Termination of defibrillation |
| Measure | Description | Time Frame |
|---|---|---|
| Survival to Hospital Discharge | 30 days | |
| Resuscitation for Survival to One Hour | One hour from termination of defibrillation | |
| Neurologic Function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Stiell, MD | OHRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Hospital | Ottawa | Ontario | K1Y 4E9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17353443 | Result | Stiell IG, Walker RG, Nesbitt LP, Chapman FW, Cousineau D, Christenson J, Bradford P, Sookram S, Berringer R, Lank P, Wells GA. BIPHASIC Trial: a randomized comparison of fixed lower versus escalating higher energy levels for defibrillation in out-of-hospital cardiac arrest. Circulation. 2007 Mar 27;115(12):1511-7. doi: 10.1161/CIRCULATIONAHA.106.648204. Epub 2007 Mar 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fixed Lower-energy | Out-of-hospital cardiac arrest patients undergoing defibrillation received a fixed lower-energy regimen of 150 J for all shocks |
| FG001 | Escalating Higher-energy | Out-of-hospital cardiac arrest patients undergoing defibrillation received an escalating higher-energy regimen beginning with 200 J, proceeding to 300 J for the second shock and 360 J for all remaining shocks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fixed Lower-energy | Out-of-hospital cardiac arrest patients undergoing defibrillation received a fixed lower-energy regimen of 150 J for all shocks |
| BG001 | Escalating Higher-energy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Successful Conversion to an Organized Heart Rhythm | Posted | Count of Participants | Participants | Termination of defibrillation |
|
30 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 | Fixed Lower-energy | Out-of-hospital cardiac arrest patients undergoing defibrillation received a fixed lower-energy regimen of 150 J for all shocks |
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None applicable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ian G. Stiell, Senior Scientist | Ottawa Hospital Research Institute | 613-798-5555 | 18683 | istiell@ohri.ca |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
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| Escalating higher-energy defibrillation |
| Procedure |
First shock administered at 200 J, second shock at 300 J, all subsequent shocks at 360 J |
|
The Cerebral Performance Category Score (CPC) is a five-point scale used to assess neurological outcomes after cardiac arrest. The best score, 1, indicates good cerebral performance. The worst score, 5, represents brain death. |
| 30 days |
| Return of Spontaneous Circulation | Termination of defibrillation |
| Survival to 24 Hours | 24 hours |
Out-of-hospital cardiac arrest patients undergoing defibrillation received an escalating higher-energy regimen beginning with 200 J, proceeding to 300 J for the second shock and 360 J for all remaining shocks
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Initial Rhythm | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Survival to Hospital Discharge | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Resuscitation for Survival to One Hour | Posted | Count of Participants | Participants | One hour from termination of defibrillation |
|
|
|
| Secondary | Neurologic Function | The Cerebral Performance Category Score (CPC) is a five-point scale used to assess neurological outcomes after cardiac arrest. The best score, 1, indicates good cerebral performance. The worst score, 5, represents brain death. | Patients who survived to hospital discharge | Posted | Median | Inter-Quartile Range | score on a scale | 30 days |
|
|
|
| Secondary | Return of Spontaneous Circulation | Posted | Count of Participants | Participants | Termination of defibrillation |
|
|
|
| Secondary | Survival to 24 Hours | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| 0 |
| 114 |
| 0 |
| 114 |
| EG001 | Escalating Higher-energy | Out-of-hospital cardiac arrest patients undergoing defibrillation received an escalating higher-energy regimen beginning with 200 J, proceeding to 300 J for the second shock and 360 J for all remaining shocks | 0 | 107 | 0 | 107 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |