Timely Acquirement of 12-lead ECG Using Patchy-type Wireless Device Among Patient With Chest Pain

October 21, 2020 updated by: Samsung Medical Center

Timely Acquirement of 12-lead Electrocardiography Using Patchy-type Wireless Device Among Patient With Chest Pain in Emergency Departement

In this study, the investigators compare timely acquirement of 12-lead ECG using patchy-type wireless versus using standard 12-lead ECG system among patient with chest pain in ED. 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 hospital delay in ED between two groups. The participants were randomly divided into 2 groups: one performing an ECG examination using the standard 12-lead ECG and the other using the patch-type mobile 12-lead ECG.The 12-lead ECG will be taken 2 times serially in every 15 minutes.

Study Overview

Status

Completed

Detailed Description

  1. research background Electrocardiography (ECG) is the most important diagnostic tool for rapid detection of acute coronary syndrome, and should be performed and interpreted promptly on appearance of symptoms. Early detection of ST-elevation myocardial infarction (STEMI) on a 12-lead ECG, within 10 minutes after the first medical contact before hospitalization not only minimizes the time taken for diagnosis and reperfusion therapy but also increases the chances of patient survival and preservation of myocardial function.

    However, it is challenging to perform a 12-lead ECG promptly using the standard 12-lead ECG system for several reasons. First, it is difficult to identify the landmarks for the 10-electrode configuration of the standard ECG. Second, electrodes on the extremities often cause artifacts due to body and muscle movements. Moreover, most of the standard 12-lead ECG systems have cables connected to the precordial and limb leads, which frequently get entangled and disorganized, and can be difficult to manage.Most importantly, its accuracy is dependent on the operators' experience; not just that of the nurses or emergency medical technicians, but also of cardiologists.These difficulties might increase the time taken to perform an ECG especially in pre-hospital situations.

  2. Objective 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 hospital delay in ED between two groups.
  3. Design : Randomized controlled trial
  4. Setting : ED at the Samsung medical center
  5. Enrollment : 36 patients who visited the ED with chest pain
  6. Intervention Standard 12-lead ECG will be performed at the time of visiting ED to the participants with chest pain.

ED physicians will prescribe to perform second and third 12-lead ECG in every 15 minutes.

  1. Control group : Second and third 12 lead ECG will be taken using standard 12-lead ECG device as a doctor's order.
  2. Study group :Second and third 12 lead ECG will be taken using patchy-type 12-lead ECG device as a doctor's order.

7. scoring To measure, interval from the anticipated time to take 12-lead ECG to the time actually performed will be measured. The duration from the anticipated time to the time of verification by physician will be also measured.

8. study period The experiment ends when patient who agreed to participate in the study discharged the ED.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gangnam
      • Seoul, Gangnam, Korea, Republic of, 06351
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A subject who visited the ER with a cardiogenic chest pain
  • adult patients over 19 years of age
  • A subject who completed the 1st ECG

Exclusion Criteria:

  • A subject who did not agree with this study
  • arrest patient
  • Dead on arrival
  • STEMI patients who confirmed by 1st ECG in ER
  • shock status patient in triage state

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patchy type-lead ECG

ED physicians will prescribe to perform second and third 12-lead ECG in every 15 minutes.

Second and third 12 lead ECG will be taken using patchy-type 12-lead ECG device as a doctor's order. This device will be automatically record 12-lead ECG 3 times in 1 minutes at a time by its algorithm.

Perform 12-lead ECG using patchy-type wireless 12-lead ECG. This device automatically record 12-lead ECG in every 15 minutes by its algorithm.
NO_INTERVENTION: Standard 12-lead ECG

ED physicians will prescribe to perform second and third 12-lead ECG in every 15 minutes.

Second and third 12 lead ECG will be taken using standard 12-lead ECG device as a doctor's order. Interns and ECG technicians will perform 12-lead ECG as they perform as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from ordering to performing 12-lead ECGs during up to 24 hours in ED.
Time Frame: measure the time duration from ECG ordering to performing during up to 24 hours in ED
Comparison of interval from the anticipated time to take 12-lead ECG to the time actually performed will be measured.
measure the time duration from ECG ordering to performing during up to 24 hours in ED
Time from ordering to verifying 12-lead ECGs by ED physician during up to 24 hours in ED.
Time Frame: measure the time duration from ECG ordering to verifying by ED physician during up to 24 hours in ED
Comparison of interval from the anticipated time to take 12-lead ECG to the time verified by physician
measure the time duration from ECG ordering to verifying by ED physician during up to 24 hours in ED

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Presence of artifacts in 12-lead ECGs.
Time Frame: ECG reading and checking of presence of artifacts in 12 lead ECGs through study completion, an average of 1 month.
Comparison of the presence of artifacts in 12-lead ECGs in intervention group and control group
ECG reading and checking of presence of artifacts in 12 lead ECGs through study completion, an average of 1 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: wonchul cha, doctoral, Samsumg Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 30, 2019

Primary Completion (ACTUAL)

October 8, 2019

Study Completion (ACTUAL)

December 16, 2019

Study Registration Dates

First Submitted

July 31, 2019

First Submitted That Met QC Criteria

August 5, 2019

First Posted (ACTUAL)

August 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-01-046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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