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

NCT04048733 | Completed

• 1 other identifier: 2019-01-046
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain; Electrocardiography

Keywords

Electrocardiography; Chest pain; Emergency Service,Hospital; Wireless Technology

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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 Outcomes (1)

• The Presence of artifacts in 12-lead ECGs.

  ECG reading and checking of presence of artifacts in 12 lead ECGs through study completion, an average of 1 month.

Study Arms (2)

Patchy type-lead ECG

EXPERIMENTAL

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.

Device: patchy-type wireless 12-lead ECG

Standard 12-lead ECG

NO INTERVENTION

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.

Interventions

patchy-type wireless 12-lead ECG DEVICE

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.

Patchy type-lead ECG

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam, 06351, South Korea

Location

MeSH Terms

Conditions

Chest Pain; Emergencies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• wonchul cha, doctoral

  samsumg medical center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 7, 2019
• Study Start: July 30, 2019
• Primary Completion: October 8, 2019
• Study Completion: December 16, 2019
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)