search
Back to results

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

Primary Purpose

Chest Pain, Electrocardiography

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
patchy-type wireless ECG
defibrillator ECG
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chest Pain focused on measuring 12-lead electrocardiography, Emergency medical technician, chest pain, wireless technology, simulation study

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A : defibrillator ECG to patchy-type ECG

Group B : patchy-type ECG to defibrillator ECG

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Usability of patchy-type wireless ECG device.
System Usability Scale survey of patchy-type wireless ECG device

Full Information

First Posted
September 30, 2019
Last Updated
October 21, 2020
Sponsor
Samsung Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04114760
Brief Title
Timely Acquirement of 12-lead ECG Using Patchy-type Wireless Device by Emergency Medical Technician in Ambulance
Official Title
Timely Acquirement of 12-lead Electrocardiography Using Patchy-type Wireless Device by Emergency Medical Technicians in Ambulance ; A Simulation Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 25, 2019 (Actual)
Primary Completion Date
December 16, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Electrocardiography
Keywords
12-lead electrocardiography, Emergency medical technician, chest pain, wireless technology, simulation study

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A : defibrillator ECG to patchy-type ECG
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B : patchy-type ECG to defibrillator ECG
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
patchy-type wireless ECG
Intervention Description
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
Intervention Name(s)
defibrillator ECG
Intervention Description
This device is essential equipment in ambulance. For 12-lead ECG examination the connector need to replace for specific cable.
Primary Outcome Measure Information:
Title
Time from 12-lead ECG device application starting to sending ECG result to hospital.
Description
comparison of interval from the start of 12-lead ECG device application to complete of ECG result sending
Time Frame
through study completion, an average of 2 month
Secondary Outcome Measure Information:
Title
Usability of patchy-type wireless ECG device.
Description
System Usability Scale survey of patchy-type wireless ECG device
Time Frame
survey collecting through study completion an average of 2 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tearim kim, doctoral
Organizational Affiliation
samsumg medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
36099010
Citation
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.
Results Reference
derived
PubMed Identifier
33792550
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs