Recognizing Ventricular Fibrillation From an Area of a Mobile Phone

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.

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Key information

Conditions

Ventricular Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North Karelia Central Hospital, Joensuu, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

age over 18
ventricular fibrillation will be induced during the implantation or revision of ICD
patient's informed consent

Exclusion criteria

ventricular fibrillation will not be induced during the implantation or revision of ICD

Treatment and study plan

Primary outcomes

The ability of AED to recognise induced VF

Time frame: 24 hours

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?

Secondary outcomes

Quality of VF

Time frame: 24 hour

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.

Sponsors and collaborators

Lead sponsor

North Karelia Central Hospital

Other

Collaborators

Kuopio University Hospital

Registry information

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Apr 4, 2013
Registry last updated: Mar 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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