Timely Acquirement of 12-lead ECG Using Patchy-type Wireless Device by Emergency Medical Technician in Ambulance

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT04114760

Collaborator

(none)

Enrollment

Location

Arms

2.2

Actual Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, the investigators compare timely acquirement and effectiveness of 12-lead ECG using patchy-type wireless versus using defibrillator which contain ECG examination function in ambulance.

The purpose of this study is to determine the difference of timely acquirement of 12-lead ECG using two different systems and the difference of efficiency of ECG examination in ambulance between two groups.

The participants in this simulation study were divided randomly into 2 groups :

Group A is performing an ECG examination on mock patient using defibrillator which contained 12-lead ECG checking function. And take a 15 minutes wash out period. After the wash out period, group A subject performing an ECG examination using patchy-type wireless device.

Group B subject is performing an ECG examination on mock patient using patchy-type wireless device first, and take a 15 minutes wash out period. After the wash out period, group B performing an ECG examination using defibrillator which contain 12-lead ECG function.

Both group's ECG examination is performing in the ambulance.

Condition or Disease	Intervention/Treatment	Phase
Chest Pain Electrocardiography	Device: patchy-type wireless ECG Device: defibrillator ECG	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Timely Acquirement of 12-lead Electrocardiography Using Patchy-type Wireless Device by Emergency Medical Technicians in Ambulance ; A Simulation Study

Actual Study Start Date :

Oct 25, 2019

Actual Primary Completion Date :

Dec 16, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A : defibrillator ECG to patchy-type ECG Group A subject will performing ECG examination to a mock patient in the ambulance. First ECG performance will be using defibrillator which contain 12-lead ECG checking function. And taking a 15 minutes wash out period. Second ECG performance after wash out period, will be using patchy-type wireless device. when ECG examination performance ended, survey of patchy-type wireless ECG device usability will be collect.	Device: defibrillator ECG This device is essential equipment in ambulance. For 12-lead ECG examination the connector need to replace for specific cable.
Experimental: Group B : patchy-type ECG to defibrillator ECG Group B subject will performing ECG examination to a mock patient in the ambulance. First ECG performance will be using patchy-type wireless device. And taking a 15 minutes wash out period. Second ECG performance after wash out period, will be using defibrillator which contain 12-lead ECG checking function. when ECG examination performance ended, survey of patchy-type wireless ECG device usability will be collect.	Device: patchy-type wireless ECG This device consists of a single patchy and save the ECG result as a Potable Document Format. Also can transfer to hospital using wifi-network.

Arm

Intervention/Treatment

Active Comparator: Group A : defibrillator ECG to patchy-type ECG

Group A subject will performing ECG examination to a mock patient in the ambulance. First ECG performance will be using defibrillator which contain 12-lead ECG checking function. And taking a 15 minutes wash out period. Second ECG performance after wash out period, will be using patchy-type wireless device. when ECG examination performance ended, survey of patchy-type wireless ECG device usability will be collect.

Device: defibrillator ECG

This device is essential equipment in ambulance. For 12-lead ECG examination the connector need to replace for specific cable.

Experimental: Group B : patchy-type ECG to defibrillator ECG

Group B subject will performing ECG examination to a mock patient in the ambulance. First ECG performance will be using patchy-type wireless device. And taking a 15 minutes wash out period. Second ECG performance after wash out period, will be using defibrillator which contain 12-lead ECG checking function. when ECG examination performance ended, survey of patchy-type wireless ECG device usability will be collect.

Device: patchy-type wireless ECG

This device consists of a single patchy and save the ECG result as a Potable Document Format. Also can transfer to hospital using wifi-network.

Outcome Measures

Primary Outcome Measures

Time from 12-lead ECG device application starting to sending ECG result to hospital. [through study completion, an average of 2 month]
comparison of interval from the start of 12-lead ECG device application to complete of ECG result sending

Secondary Outcome Measures

Usability of patchy-type wireless ECG device. [survey collecting through study completion an average of 2 month]
System Usability Scale survey of patchy-type wireless ECG device

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Who have a certification of Emergency Medical Technician in korea and have a nurse license in korea.
who currently engaged of emergency medical dispatch.