Cardiac Arrest
Conditions
Keywords
defibrillation, ventricular fibrillation, heart arrest
Brief summary
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.
Detailed description
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: 1. Important Clinical Outcomes: * Successful conversion, * Resuscitation to one hour, * Survival to hospital discharge, * Neurological function, and * Quality of life. 2. Process Outcomes: * Number of shocks required, * Recurrences of VF, and * Responsiveness to varying periods of pulselessness. 3. Adverse Outcomes: * Myocardial damage.
Interventions
PROCEDUREFixed lower-energy defibrillation
Every shock administered at 150 J
PROCEDUREEscalating higher-energy defibrillation
First shock administered at 200 J, second shock at 300 J, all subsequent shocks at 360 J
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Witnessed cardiac arrest out-of-hospital requiring defibrillation and given by first responder using an automated external defibrillator
Exclusion criteria
* Terminal illness or do-not-resuscitate (DNR) status * No cardiopulmonary resuscitation (CPR) x 10 minutes * Acute trauma * Exsanguination * Cardiac arrest experienced while in hospital
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful Conversion to an Organized Heart Rhythm | Termination of defibrillation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival to Hospital Discharge | 30 days | — |
| Resuscitation for Survival to One Hour | One hour from termination of defibrillation | — |
| Neurologic Function | 30 days | 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. |
| Return of Spontaneous Circulation | Termination of defibrillation | — |
| Survival to 24 Hours | 24 hours | — |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fixed Lower-energy Out-of-hospital cardiac arrest patients undergoing defibrillation received a fixed lower-energy regimen of 150 J for all shocks | 114 |
| 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 | 107 |
| Total | 221 |
Baseline characteristics
| Characteristic | Escalating Higher-energy | Total | Fixed Lower-energy |
|---|---|---|---|
| Age, Continuous | 66.1 Years STANDARD_DEVIATION 14.5 | 66.0 Years STANDARD_DEVIATION 14.4 | 66.0 Years STANDARD_DEVIATION 14.2 |
| Initial Rhythm Asystole | 0 Participants | 6 Participants | 6 Participants |
| Initial Rhythm Pulseless electrical activity | 4 Participants | 9 Participants | 5 Participants |
| Initial Rhythm VT/VF | 103 Participants | 206 Participants | 103 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Canada | 107 participants | 221 participants | 114 participants |
| Sex: Female, Male Female | 18 Participants | 44 Participants | 26 Participants |
| Sex: Female, Male Male | 89 Participants | 177 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 114 | 0 / 107 |
| serious Total, serious adverse events | 0 / 114 | 0 / 107 |
Outcome results
Primary
Successful Conversion to an Organized Heart Rhythm
Time frame: Termination of defibrillation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fixed Lower-energy | Successful Conversion to an Organized Heart Rhythm | 28 Participants |
| Escalating Higher-energy | Successful Conversion to an Organized Heart Rhythm | 39 Participants |
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.
Time frame: 30 days
Population: Patients who survived to hospital discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fixed Lower-energy | Neurologic Function | 2 score on a scale |
| Escalating Higher-energy | Neurologic Function | 2 score on a scale |
Secondary
Resuscitation for Survival to One Hour
Time frame: One hour from termination of defibrillation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fixed Lower-energy | Resuscitation for Survival to One Hour | 54 Participants |
| Escalating Higher-energy | Resuscitation for Survival to One Hour | 44 Participants |
Secondary
Return of Spontaneous Circulation
Time frame: Termination of defibrillation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fixed Lower-energy | Return of Spontaneous Circulation | 58 Participants |
| Escalating Higher-energy | Return of Spontaneous Circulation | 52 Participants |
Secondary
Survival to 24 Hours
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fixed Lower-energy | Survival to 24 Hours | 37 Participants |
| Escalating Higher-energy | Survival to 24 Hours | 38 Participants |
Secondary
Survival to Hospital Discharge
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fixed Lower-energy | Survival to Hospital Discharge | 19 Participants |
| Escalating Higher-energy | Survival to Hospital Discharge | 17 Participants |