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

Chest Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04114760
• Other study ID #: 2019-04-004
• Status: Completed
• Phase: N/A
• Start date: October 25, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 31, 2019
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.

Exclusion Criteria:

• A subject who did not agree with this study

Related Conditions & MeSH terms

• Chest Pain
• Electrocardiography
• Emergencies

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from 12-lead ECG device application starting to sending ECG result to hospital.	comparison of interval from the start of 12-lead ECG device application to complete of ECG result sending	through study completion, an average of 2 month
Secondary	Usability of patchy-type wireless ECG device.	System Usability Scale survey of patchy-type wireless ECG device	survey collecting through study completion an average of 2 month