Recognizing Ventricular Fibrillation From an Area of a Mobile Phone

NCT ID: NCT01824212

Last Updated: 2016-03-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-03-31

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.

Conditions

Ventricular Fibrillation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

ICD-patients

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kuopio University Hospital

OTHER

Sponsor Role: collaborator

North Karelia Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sakari Syvaoja

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helena Jäntti, MD, PhD

Role: STUDY_DIRECTOR

Kuopio University Hospital

Sakari Syväoja, MD

Role: PRINCIPAL_INVESTIGATOR

North Karelia Central Hospital

Locations

North Karelia Central Hospital

Joensuu, , Finland

Kuopio University Hospital

Kuopio, , Finland

Countries

Finland

Other Identifiers

NKCHAne001

Identifier Type: -

Identifier Source: org_study_id