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Clinical Trials/NCT01824212
NCT01824212CompletedNot Applicable

Recognizing Ventricular Fibrillation From an Area of a Mobile Phone

North Karelia Central Hospital2 sites in 1 country22 target enrollmentStarted: November 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
22
Locations
2
Primary Endpoint
The ability of AED to recognise induced VF

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

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(24 hour)

Investigators

Sponsor
North Karelia Central Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sakari Syvaoja

MD

North Karelia Central Hospital

Study Sites (2)

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