An observational study in Ventricular Fibrillation, sponsored by North Karelia Central Hospital. Completed at 2 sites in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-23.
Sponsored by North Karelia Central Hospital · Observational
Recognition of out of hospital cardiac arrest (OHCA) during an emergency call is based on standardized questions concerning the symptoms of OHCA. With this method cardiac arrest is recognized in 50-83% of cases. When the emergency medical dispatcher identifies cardiac arrest during the emergency call the survival of the patient improves. Accurate emergency medical service response is activated promptly and bystander will receive cardiopulmonary resuscitation (CPR) instructions. It has been estimated that proper implementation of CPR instructions will save thousands of lives each year.
If the ECG could be recorded by the mobile phone, transmitted during the emergency call to the dispatch centre and analysed there with the software of a semi-automated external defibrillator(AED), the recognition of cardiac arrest could be more accurate.
The aim of this study is to examine, if AED, with minimal size electrodes within an area of a mobile phone, is able to recognize reliably ventricular fibrillation (VF), the rhythm with the best prognosis in OHCA.
Dysrhythmia patients who need an implantable cardioverter defibrillator(ICD) or patients with an already implanted ICD which function needs to be revised will be recruited into this study. Our hypothesis is that the ECG and VF is recordable in 100% of cases with a semi-automatic defibrillator. In sample size calculations we compared this 100% recognition to the present situation with 80% recognition of cardiac arrest in emergency medical communication centre during emergency call. According to the power calculation of 1-sided binomial test with risk level 0.05 and power of 95 %, 22 observations is needed to detect difference between expected full successes (99 %) from the previous 80 % of successes in recognition.
168 studies on the registry are indexed under Ventricular Fibrillation; 36 are open to participants now.
This study's enrollment of 22 is below the median of 441 across 76 observational studies indexed under Ventricular Fibrillation.
Browse Ventricular Fibrillation studies →North Karelia Central Hospital is the lead sponsor of 18 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with severe dysrhytmia and the necessity to an implantable cardioverter defibrillator (ICD)
Exclusion Criteria:
Patients to whom cardiac fibrillation will be induced during the implantation of an implantable cardioverter defibrillator (ICD) or patients with an already implanted ICD, which function needs to be revised and during the revision cardiac defibrillation will be induced.
The ability of AED to recognise induced VF
The ability of AED to correctly recognise ventricular fibrillation from a bipolar ECG recorded within an area of mobile phone: is the recognition good enough to automatically divide the rhythm correctly into categories of shockable and non-shockable?
Time frame: 24 hours
Quality of VF
The recorded rhythms will be analysed, beside an AED, by two experienced cardiologists and categorised as shockable or non-shockable. The cardiologists also will assess the quality of the recordings and grade each recording according to three categories of quality: 1, bad; 2, average; 3, good.
Time frame: 24 hour
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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North Karelia Central Hospital