Clinical trial NCT01824212: Recognizing Ventricular Fibrillation From an Area of a Mobile Phone
Official title: Recognizing Ventricular Fibrillation From an Area of a Mobile Phone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Fibrillation
Keywords: Ventricular fibrillation
Cardiac arrest
Mobile technology
Lead sponsor: North Karelia Central Hospital
Sponsor class: OTHER
Collaborators: name: Kuopio University Hospital
First posted: 2013-04-04
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe dysrhytmia and the necessity to an implantable cardioverter defibrillator (ICD)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The ability of AED to recognise induced VF
timeFrame: 24 hours
Secondary outcomes:
measure: Quality of VF
timeFrame: 24 hour
Other outcomes:
Locations:
city: Joensuu
country: Finland
facility: North Karelia Central Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Kuopio University Hospital
name: Helena Jäntti, MD, PhD
role: STUDY_DIRECTOR
affiliation: North Karelia Central Hospital
name: Sakari Syväoja, MD
role: PRINCIPAL_INVESTIGATOR
References: