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

NCT04114760 | Completed

• 1 other identifier: 2019-04-004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain; Electrocardiography

Keywords

12-lead electrocardiography; Emergency medical technician; chest pain; wireless technology; simulation study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Usability of patchy-type wireless ECG device.

  survey collecting through study completion an average of 2 month

Study Arms (2)

Group A : defibrillator ECG to patchy-type ECG

ACTIVE COMPARATOR

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

Group B : patchy-type ECG to defibrillator ECG

EXPERIMENTAL

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

Interventions

patchy-type wireless ECG DEVICE

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.

Group B : patchy-type ECG to defibrillator ECG

defibrillator ECG DEVICE

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

Group A : defibrillator ECG to patchy-type ECG

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• A subject who did not agree with this study

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam, 06351, South Korea

Location

Related Publications (2)

• Yoo S, Chang H, Kim T, Yoon H, Hwang SY, Shin TG, Sim MS, Jo IJ, Choi JH, Cha WC. Intervention in the Timeliness of Two Electrocardiography Types for Patients in the Emergency Department With Chest Pain: Randomized Controlled Trial. Interact J Med Res. 2022 Sep 13;11(2):e36335. doi: 10.2196/36335.

  PMID: 36099010 DERIVED

• Yoon S, Kim T, Roh T, Chang H, Hwang SY, Yoon H, Shin TG, Sim MS, Jo IJ, Cha WC. Twelve-Lead Electrocardiogram Acquisition With a Patchy-Type Wireless Device in Ambulance Transport: Simulation-Based Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Apr 1;9(4):e24142. doi: 10.2196/24142.

  PMID: 33792550 DERIVED

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• tearim kim, doctoral

  samsumg medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 3, 2019
• Study Start: October 25, 2019
• Primary Completion: December 16, 2019
• Study Completion: December 31, 2019
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

KR (1)