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

NCT ID: NCT04114760

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-25

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chest Pain Electrocardiography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

defibrillator ECG

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

patchy-type wireless ECG

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

defibrillator ECG

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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tearim kim, doctoral

Role: PRINCIPAL_INVESTIGATOR

samsumg medical center

Locations

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Samsung Medical Center

Seoul, Gangnam, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 36099010 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33792550 (View on PubMed)

Other Identifiers

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2019-04-004

Identifier Type: -

Identifier Source: org_study_id

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