Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04048733
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Chest Pain Electrocardiography Device: patchy-type wireless 12-lead ECG Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Timely Acquirement of 12-lead Electrocardiography Using Patchy-type Wireless Device Among Patient With Chest Pain in Emergency Departement
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : December 11, 2019
Estimated Study Completion Date : February 11, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

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.

Device: patchy-type wireless 12-lead ECG
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.




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04048733


Contacts
Layout table for location contacts
Contact: sunyoung yoon 82-2-2148-7159 emtyoon92@gmail.com
Contact: Taerim Kim, doctoral 82-2-3410-1869 taerimi.kim@samsung.com

Locations
Layout table for location information
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Gangnam, Korea, Republic of, 06351
Contact: Won Chul Cha, Dr    +8234102053    wc.cha@samsung.com   
Contact: Taerim Kim, Dr    +8234102053    taerimi.kim@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Layout table for investigator information
Principal Investigator: wonchul cha, doctoral samsumg medical center

Layout table for additonal information
Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT04048733     History of Changes
Other Study ID Numbers: 2019-01-046
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samsung Medical Center:
Electrocardiography
Chest pain
Emergency Service,Hospital
Wireless Technology
Additional relevant MeSH terms:
Layout table for MeSH terms
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms