search
Back to results

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

Primary Purpose

Chest Pain, Electrocardiography

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
patchy-type wireless 12-lead 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 Electrocardiography, Chest pain, Emergency Service,Hospital, Wireless Technology

Eligibility Criteria

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

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patchy type-lead ECG

Standard 12-lead ECG

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time from ordering to performing 12-lead ECGs 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.
Time from ordering to verifying 12-lead ECGs 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

Secondary Outcome Measures

The Presence of artifacts in 12-lead ECGs.
Comparison of the presence of artifacts in 12-lead ECGs in intervention group and control group

Full Information

First Posted
July 31, 2019
Last Updated
October 21, 2020
Sponsor
Samsung Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04048733
Brief Title
Timely Acquirement of 12-lead ECG Using Patchy-type Wireless Device Among Patient With Chest Pain
Official Title
Timely Acquirement of 12-lead Electrocardiography Using Patchy-type Wireless Device Among Patient With Chest Pain in Emergency Departement
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 30, 2019 (Actual)
Primary Completion Date
October 8, 2019 (Actual)
Study Completion Date
December 16, 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

5. Study Description

Brief Summary
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.
Detailed Description
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. 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. Design : Randomized controlled trial Setting : ED at the Samsung medical center Enrollment : 36 patients who visited the ED with chest pain 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. Control group : Second and third 12 lead ECG will be taken using standard 12-lead ECG device as a doctor's order. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Electrocardiography
Keywords
Electrocardiography, Chest pain, Emergency Service,Hospital, Wireless Technology

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Patchy type-lead ECG
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard 12-lead ECG
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
patchy-type wireless 12-lead ECG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time from ordering to performing 12-lead ECGs during up to 24 hours in ED.
Description
Comparison of interval from the anticipated time to take 12-lead ECG to the time actually performed will be measured.
Time Frame
measure the time duration from ECG ordering to performing during up to 24 hours in ED
Title
Time from ordering to verifying 12-lead ECGs by ED physician during up to 24 hours in ED.
Description
Comparison of interval from the anticipated time to take 12-lead ECG to the time verified by physician
Time Frame
measure the time duration from ECG ordering to verifying by ED physician during up to 24 hours in ED
Secondary Outcome Measure Information:
Title
The Presence of artifacts in 12-lead ECGs.
Description
Comparison of the presence of artifacts in 12-lead ECGs in intervention group and control group
Time Frame
ECG reading and checking of presence of artifacts in 12 lead ECGs through study completion, an average of 1 month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wonchul cha, 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

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs