- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04048733
Timely Acquirement of 12-lead ECG Using Patchy-type Wireless Device Among Patient With Chest Pain
Timely Acquirement of 12-lead Electrocardiography Using Patchy-type Wireless Device Among Patient With Chest Pain in Emergency Departement
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gangnam
-
Seoul, Gangnam, Korea, Republic of, 06351
- Samsung Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: wonchul cha, doctoral, Samsumg Medical Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Chest Pain
-
Clinical Locomotion ScienceOdense University Hospital; University of Southern Denmark; The County of Funen... and other collaboratorsCompletedUndiagnosed Chest Pain | Musculoskeletal Chest Pain | Non-cardiac Chest PainDenmark
-
Academisch Medisch Centrum - Universiteit van Amsterdam...TerminatedFunctional Chest PainNetherlands
-
Ataturk UniversityCompletedPain, Acute | Pain, ChestTurkey
-
Queen's UniversityCompletedChest Pain Atypical SyndromeCanada
-
Universiti Sains MalaysiaCompletedNon Cardiac Chest PainMalaysia
-
Milton S. Hershey Medical CenterCompletedNoncardiac Chest Pain (NCCP)United States
-
Fayoum University HospitalCompleted
-
University of Texas Southwestern Medical CenterCompletedAcute Chest PainUnited States
-
Massachusetts General HospitalBracco Diagnostics, IncCompletedChest Pain SyndromeUnited States
-
Virginia Commonwealth UniversityWithdrawnPain, Postoperative | Pain, ChestUnited States
Clinical Trials on patchy-type wireless 12-lead ECG
-
Samsung Medical CenterCompletedChest Pain | ElectrocardiographyKorea, Republic of
-
Apple Inc.Iqvia Pty LtdCompleted
-
Apple Inc.Iqvia Pty LtdCompleted
-
Huawei Device Co., LtdCompletedArrhythmias, CardiacChina
-
Murdoch Childrens Research InstituteRecruiting
-
Mayo ClinicNot yet recruitingHypertrophic Cardiomyopathy | Athlete HeartUnited States
-
University Hospital, BordeauxRecruitingVentricular ArrhythmiasFrance
-
The Leeds Teaching Hospitals NHS TrustLeeds and York Partnership NHS Foundation TrustUnknownCardiovascular Diseases | Dementia | Mental Health DisorderUnited Kingdom
-
AliveCorRecruitingMyocardial Infarction | Ischemia | Myocardial Ischemia | Heart Diseases | Cardiovascular Diseases | Vascular Diseases | Heart Failure | Heart AttackUnited States
-
Qompium NVCompleted