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Introduction
Strategies for Defibrillation during Out-of-Hospital Cardiac Arrest - A Randomized Clinical Trial
​This educational content is required to be completed before active participation in the trial. When informed we please ask you to sign by clicking this REDCap sign button below.
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If you have completed the main educational content before, click the button below to acces the educational renewal content.
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If you are a prehospital clinician but not a doctor, physician assistant, or paramedic, please click the button below to access the introduction material for the trial.
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Introduction video
Background
Twenty percent of out-of-hospital cardiac arrest patients have an initial shockable rhythm. Approximately 75% of these do not respond to initial defibrillation attempts and only 20% of them survive.
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The guideline recommended defibrillation strategy is to shock these patients with pads placed in an anterior-lateral position. Another way is to place the pads in an anterior-posterior position. A third option, double sequential defibrillation, is a combination of the two pad placements, resulting in a setup with 4 pads and two defibrillators. Two shocks are administered separately but sequentially, ideally as close to each other as possible. A recent trial, DOSE-VF, reported improved survival rates using these alternative defibrillation strategies for patients with refractory shockable rhythms.
Overview
The objective of the current trial is to determine whether there is a difference in outcomes depending on the type of defibrillation strategy used in out-of-hospital cardiac arrest with refractory shockable rhythms.​
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The sample size for the trial is 909 patients.
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Total number of participants
909
Patients will be randomized in a 1:1:1 ratio to receive one of three defibrillation strategies.
Use the arrows to change between intervention slides
Interventions
Anterior-lateral
Patients randomized to anterior-lateral pad placement will keep their initial pad placement, with the anterior pad placed to the right of the sternum, below the clavicle. The lateral pad is placed in the mid-axillary line in level with the bottom of the pectoralis muscle for men, and below the breast for women.
For a detailed 3D view of the pad placement, please explore the model below. You can change the sex of the model.
The trial relies on you as a clinician to initiate the inclusion of the patient. While attending a cardiac arrest, you will determine when the patient meets the criteria for inclusion in the trial. The inclusion and exclusion criteria are listed below.
All of these criteria must be confirmed before opening of the randomization envelope.
All of these criteria must be confirmed before opening of the randomization envelope.
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Out-of-hospital cardiac arrest
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Age ≥ 18 years
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≥ 1 manual defibrillation attempt by emergency medical services
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Shockable rhythm as the last known rhythm
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Two manual defibrillators present on-site
Randomization is performed by opening a randomization envelope and must be done by a trial-participating clinician (physician, physician assistant, or paramedic). This envelope will be placed in the defibrillator's side pouch. The envelope may only be opened on-site when you as the responsible clinician have confirmed that the patient meet all of the inclusion criteria and none of the exclusion criteria. When the envelope is opened, the patient is included in the trial.
A randomization number is noted on the randomization envelope and the allocation slip within the envelope. The randomization number must be registered in REDCap after the intervention is finished.
Outcomes
Primary outcome
Survival at 30 days
Secondary outcomes
Survival at 90 days.
Survival at 30 and 90 days with favorable neurological outcome
Procedure demonstration
In the video below you will see a demonstration of double sequential defibrillation.
Patients allocated to the anterior-posterior intervention, will have the same anterior-posterior pad placement as demonstrated in the video, but will only receive a single shock.
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The allocated defibrillation strategy must be prepared as soon as possible, after the envelope has been opened. All subsequent defibrillation attempts must adhere to the allocated intervention. New pads must be used for the anterior-posterior position, regardless if the patient is allocated to anterior-posterior or double sequential defibrillation.
The posterior pad must be placed to the left of the thoracic spine and below the spine of the scapula. The posterior pad can be placed during the ventilation induced pause in chest compressions.
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When delivering shocks using double sequential defibrillation, the two defibrillators must be operated by the same clinician. The second defibrillator should be set to max energy settings regardless of model and manufacturer. The shocks are administered separately but sequentially, ideally as close to each other as possible.
If the patient is to receive cardiopulmonary resuscitation during transport, and it is not possible to transport the patient with two defibrillators, double sequential defibrillation will no longer be used. In this case, additional defibrillation attempts will be performed using the anterior-posterior pads.
After a patient is randomized and the allocated intervention is prepared, it is required that at least one rhythm check is performed.​
Registration
All patients that have received a defibrillation attempt by emergency medical services must be entered into the REDCap registration - this includes both patients that were included in the trial and patients that were not included in the trial.
The registration is web-based and can be accessed on any computer or phone, both work and private devices.
After you have completed this trial education, it will be your responsibility to register the patients. The registration will take 3-5 minutes for included patients and 1-2 minutes for patients that received a defibrillation attempt without being included in the trial.
Patients with out-of-hospital cardiac arrest, that never received a defibrillation attempt during resuscitation.
No REDCap registration
Patients with out-of-hospital cardiac arrest, that received ≥1 defibrillation attempts during resuscitation.
REDCap registration
Patients with out-of-hospital cardiac arrest, that received ≥1 defibrillation attempts and the STRAT-DEFI envelope were opened.
REDCap inclusion registration
The link to REDCap can be found on the trial website, by going to redcap.link/strat.defi, or by scanning the QR-code located on the randomization envelope.
The videos below shows an example of a registration of an included patient and a patient that was not included.
Inclusion
Screening
Thank you
Thank you for completing the educational material for the STRAT-DEFI trial.
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After you sign the REDCap survey confirming your trial education, you will be eligible to include patients in the trial.
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A renewal of education is planned at 6 months after you sign and is less extensive than the main educational content.