Recognizing Ventricular Fibrillation From an Area of a Mobile Phone

Ventricular Fibrillation Clinical Trial

Official title:

Recognizing Ventricular Fibrillation From an Area of a Mobile Phone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824212
• Other study ID #: NKCHAne001
• Status: Completed
• Phase: N/A
• First received: March 27, 2013
• Last updated: March 22, 2016
• Start date: November 2013
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: North Karelia Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Valvira - National Supervisory Authority for Welfare and Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ventricular Fibrillation

Locations

Country	Name	City	State
Finland	North Karelia Central Hospital	Joensuu
Finland	Kuopio University Hospital	Kuopio

Sponsors (2)

Lead Sponsor	Collaborator
North Karelia Central Hospital	Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quality of VF	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.	24 hour	No