Dataset Information

DOuble SEquential External Defibrillation for Refractory Ventricular Fibrillation (DOSE VF): study protocol for a randomized controlled trial.

ABSTRACT:

Background

Despite high-quality cardiopulmonary resuscitation (CPR), early defibrillation, and antiarrhythmic medications, some patients remain in refractory ventricular fibrillation (VF) during out-of-hospital cardiac arrest. These patients have worse outcomes compared to patients who respond to initial treatment. Double sequential external defibrillation (DSED) and vector change (VC) defibrillation have been proposed as viable options for patients in refractory VF. However, the evidence supporting the use of novel defibrillation strategies is inconclusive. The objective of this study is to compare two novel therapeutic defibrillation strategies (DSED and VC) against standard defibrillation for patients with treatment refractory VF or pulseless ventricular tachycardia (pVT) during out-of-hospital cardiac arrest.

Research question

Among adult (≥ 18 years) patients presenting in refractory VF or pulseless ventricular tachycardia (pVT) during out-of-hospital cardiac arrest, does DSED or VC defibrillation result in greater rates of survival to hospital discharge compared to standard defibrillation?

Methods

This will be a three-arm, cluster randomized trial with repeated crossover conducted in six regions of Ontario, Canada (Peel, Halton, Toronto, Simcoe, London, and Ottawa), over 3 years. All adult (≥ 18 years) patients presenting in refractory VF (defined as patients presenting in VF/pVT and remaining in VF/pVT after three consecutive standard defibrillation attempts during out-of-hospital cardiac arrest of presumed cardiac etiology will be treated by one of three strategies: (1) continued resuscitation using standard defibrillation, (2) resuscitation involving DSED, or (3) resuscitation involving VC (change of defibrillation pads from anterior-lateral to anterior-posterior pad position) defibrillation. The primary outcome will be survival to hospital discharge. Secondary outcomes will include return of spontaneous circulation (ROSC), VF termination after the first interventional shock, VF termination inclusive of all interventional shocks, and number of defibrillation attempts to obtain ROSC. We will also perform an a priori subgroup analysis comparing rates of survival for those who receive "early DSED," or first DSED shock is shock 4-6, to those who receive "late DSED," or first DSED shock is shock 7 or later.

Discussion

A well-designed randomized controlled trial employing a standardized approach to alternative defibrillation strategies early in the treatment of refractory VF is urgently required to determine if the treatments of DSED or VC defibrillation impact clinical outcomes.

Trial registration

ClinicalTrials.gov NCT04080986 . Registered on 6 September 2019.

SUBMITTER: Drennan IR

PROVIDER: S-EPMC7689391 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundExternal defibrillators are used for arrhythmia cardioversion and for defibrillating during cardiac arrest. During defibrillation, short-duration biphasic pulses cause intense motion due to rapid chest-wall muscle contraction. A reduced motion external defibrillator (RMD) was constructed by integrating a commercial defibrillator with a Tetanizing-waveform generator. A long-duration, low-amplitude, tetanizing waveform slowly stimulated the chest musculature before the biphasic pulse, reducing muscle contraction during the shock.ObjectiveThe purpose of this study was to evaluate RMD defibrillation in swine for subject motion during defibrillation pulses and for defibrillation effectiveness. RMD defibrillation can reduce the duration of arrhythmia ablation therapy or simplify cardioversion procedures.MethodsThe tetanizing unit delivered a triangular 1-kHz pulse of 0.25- to 2.0-second duration and 10- to 100-V peak amplitude, subsequently triggering the conventional defibrillator to output standard 1- to 200-J energy biphasic pulses at the next R wave. Forward limb motion was evaluated by measuring peak acceleration and limb work during RMD (tetanizing + biphasic) or biphasic pulse-only waveforms at 10-3-second sampling rate. Seven swine were arrested electrically and subsequently defibrillated. Biphasic pulse-only and RMD defibrillations were repeated 25-35 times per swine, varying tetanizing parameters and biphasic pulse energy. Defibrillation thresholds (DFTs) were established by measuring the minimum energy required to restore sinus rhythm with biphasic pulse-only or RMD defibrillations.ResultsTwo forward-limb acceleration peaks occurred during both the tetanizing waveform and biphasic pulse, indicating rapid and slower nociceptic (pain sensation) nerve fiber activation. Optimal RMD tetanizing parameters (25-35 V, 0.25- to 0.75-second duration), relative to biphasic pulse-only defibrillations, resulted in 74% ± 10% smaller peak accelerations and 85% ± 10% reduced limb work. DFT energies were identical when comparing RMD to biphasic pulse-only defibrillations.ConclusionRelative to conventional defibrillations, RMD defibrillations maintain rhythm restoration efficiency with drastically reduced subject motion.

Project description:BackgroundMeasures of the ventricular fibrillation (VF) waveform may enable better allocation of cardiac arrest treatment by discriminating which patients should receive immediate defibrillation versus alternate therapies such as CPR. We derive a new measure based on the 'roughness' of the VF waveform, the Logarithm of the Absolute Correlations (LAC), and assess and contrast how well the LAC and the previously published scaling exponent (ScE) predict the duration of VF and the likelihood of return of spontaneous circulation (ROSC) under both optimal experimental and commercial-defibrillator sampling conditions.Methods and resultsWe derived the LAC and ScE from two different populations--an animal study of 44 swine and a retrospective human sample of 158 out-of-hospital VF arrests treated with a commercial defibrillator. In the animal study, the LAC and ScE were calculated on 5s epochs of VF recorded at 1000 samples/s and then down sampled to 125 samples/s. In the human study, the LAC and ScE were calculated using 6s epochs recorded at 200 samples/s that occurred immediately prior to the initial shock. We compared the LAC and ScE measures using the Spearman correlation coefficients (CC) and areas under the receiver operating characteristic curve (AUC).ResultsIn the animal study, the LAC and ScE were highly correlated at 1000 sample/s (CC=0.93) but not at 125 samples/s (CC=-0.06). These correlations were reflected in how well the measures discriminated VF of < or =5 versus >5 min: AUC at 1000 samples/s was similar for LAC compared to ScE (0.71 versus 0.76). However AUC at 125 samples was greater for LAC compared to ScE (0.75 versus 0.62). In the human study, the LAC measure was a better predictor of ROSC following initial defibrillation as reflected by an AUC of 0.77 for LAC compared to 0.57 for ScE.ConclusionsThe LAC is an improvement over the ScE because the LAC retains its prognostic characteristics at lower ECG sampling rates typical of current clinical defibrillators. Hence, the LAC may have a role in better allocating treatment in resuscitation of VF cardiac arrest.