An interventional study of patchy-type wireless ECG and defibrillator ECG in Chest Pain and Electrocardiography, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Other
In this study, the investigators compare timely acquirement and effectiveness of 12-lead ECG using patchy-type wireless versus using defibrillator which contain ECG examination function in ambulance.
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 efficiency of ECG examination in ambulance between two groups.
The participants in this simulation study were divided randomly into 2 groups :
Group A is performing an ECG examination on mock patient using defibrillator which contained 12-lead ECG checking function. And take a 15 minutes wash out period. After the wash out period, group A subject performing an ECG examination using patchy-type wireless device.
Group B subject is performing an ECG examination on mock patient using patchy-type wireless device first, and take a 15 minutes wash out period. After the wash out period, group B performing an ECG examination using defibrillator which contain 12-lead ECG function.
Both group's ECG examination is performing in the ambulance.
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's enrollment of 24 is below the median of 145 across 931 interventional studies indexed under Emergencies.
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Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Exclusion Criteria:
Group A subject will performing ECG examination to a mock patient in the ambulance. First ECG performance will be using defibrillator which contain 12-lead ECG checking function. And taking a 15 minutes wash out period. Second ECG performance after wash out period, will be using patchy-type wireless device. when ECG examination performance ended, survey of patchy-type wireless ECG device usability will be collect.
Device: defibrillator ECG
Group B subject will performing ECG examination to a mock patient in the ambulance. First ECG performance will be using patchy-type wireless device. And taking a 15 minutes wash out period. Second ECG performance after wash out period, will be using defibrillator which contain 12-lead ECG checking function. when ECG examination performance ended, survey of patchy-type wireless ECG device usability will be collect.
Device: patchy-type wireless ECG
This device consists of a single patchy and save the ECG result as a Potable Document Format. Also can transfer to hospital using wifi-network.
This device is essential equipment in ambulance. For 12-lead ECG examination the connector need to replace for specific cable.
Time from 12-lead ECG device application starting to sending ECG result to hospital.
comparison of interval from the start of 12-lead ECG device application to complete of ECG result sending
Time frame: through study completion, an average of 2 month
Usability of patchy-type wireless ECG device.
System Usability Scale survey of patchy-type wireless ECG device
Time frame: survey collecting through study completion an average of 2 month
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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