Recognizing Ventricular Fibrillation From an Area of a Mobile Phone

NCT01824212 | Completed

• 1 other identifier: NKCHAne001
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Ventricular Fibrillation

Keywords

Ventricular fibrillation; Cardiac arrest; Mobile technology

Outcome Measures

Primary Outcomes (1)

• 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?

  24 hours

Secondary Outcomes (1)

• Quality of VF

  24 hour

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe dysrhytmia and the necessity to an implantable cardioverter defibrillator (ICD)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• North Karelia Central Hospital: lead
• Kuopio University Hospital: collaborator

Study Sites (2)

North Karelia Central Hospital

Joensuu, 80210, Finland

Location

Kuopio University Hospital

Kuopio, 70211, Finland

Location

MeSH Terms

Conditions

Ventricular Fibrillation; Heart Arrest

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Helena Jäntti, MD, PhD

  Kuopio University Hospital

  STUDY DIRECTOR

• Sakari Syväoja, MD

  North Karelia Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 4, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 23, 2016

Record last verified: 2016-03

Locations

FI (2)