Chest PainNCT04114760
Timely Acquirement of 12-lead ECG Using Patchy-type Wireless Device by Emergency Medical Technician in Ambulance
A study testing patchy-type wireless ECG and defibrillator ECG in people with Chest Pain and Electrocardiography, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chest Pain, Electrocardiography
- What is being tested?
- patchy-type wireless ECG and defibrillator ECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Oct 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Who have a certification of Emergency Medical Technician in korea and have a nurse license in korea.
- who currently engaged of emergency medical dispatch.
Who cannot join
- A subject who did not agree with this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Timely Acquirement of 12-lead Electrocardiography Using Patchy-type Wireless Device by Emergency Medical Technicians in Ambulance ; A Simulation Study
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.
Read more
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.
- Conditions
- Chest Pain, Electrocardiography
- Being tested
- patchy-type wireless ECG, defibrillator ECG
- Keywords
- 12-lead electrocardiography, Emergency medical technician, chest pain, wireless technology, simulation study
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patchy-type wireless ECGDevice
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.
defibrillator ECGDevice
This device is essential equipment in ambulance. For 12-lead ECG examination the connector need to replace for specific cable.
| Study group | Role | What they receive |
|---|---|---|
| Group A : defibrillator ECG to patchy-type ECG | Active comparator | 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. Receives: Device: defibrillator ECG |
| Group B : patchy-type ECG to defibrillator ECG | Experimental | 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. Receives: Device: patchy-type wireless ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 2 month
Secondary outcomes (1)
Usability of patchy-type wireless ECG device.
System Usability Scale survey of patchy-type wireless ECG device
Measured: survey collecting through study completion an average of 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start25 Oct 2019
- Primary completion16 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- tearim kim, doctoral, Principal investigator, samsumg medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114760
- Sponsor's protocol ID
- 2019-04-004
- Status last verified
- Oct 2020
- First submitted
- 30 Sep 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yoo S, Chang H, Kim T, Yoon H, Hwang SY, Shin TG, Sim MS, Jo IJ, Choi JH, Cha WC. Intervention in the Timeliness of Two Electrocardiography Types for Patients in the Emergency Department With Chest Pain: Randomized Controlled Trial. Interact J Med Res. 2022 Sep 13;11(2):e36335. doi: 10.2196/36335.
PubMed 36099010Yoon S, Kim T, Roh T, Chang H, Hwang SY, Yoon H, Shin TG, Sim MS, Jo IJ, Cha WC. Twelve-Lead Electrocardiogram Acquisition With a Patchy-Type Wireless Device in Ambulance Transport: Simulation-Based Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Apr 1;9(4):e24142. doi: 10.2196/24142.
PubMed 33792550
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timely Acquirement of 12-lead Electrocardiography Using Patchy-type Wireless Device by Emergency Medical Technicians in Ambulance ; A Simulation Study
- ClinicalTrials.gov ID
- NCT04114760
- Acronym / sponsor ID
- 2019-04-004
- Conditions
- Chest Pain, Electrocardiography
- Keywords
- 12-lead electrocardiography, Emergency medical technician, chest pain, wireless technology, simulation study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A : defibrillator ECG to patchy-type ECG | Active comparator | Device: defibrillator ECGGroup 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. |
| Group B : patchy-type ECG to defibrillator ECG | Experimental | Device: patchy-type wireless ECGGroup 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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Who have a certification of Emergency Medical Technician in korea and have a nurse license in korea.
- who currently engaged of emergency medical dispatch.
Key exclusion criteria (1 listed)
- A subject who did not agree with this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patchy-type wireless ECGThis device consists of a single patchy and save the ECG result as a Potable Document Format. Also can transfer to hospital using wifi-network. | Device | Group B : patchy-type ECG to defibrillator ECG |
| defibrillator ECGThis device is essential equipment in ambulance. For 12-lead ECG examination the connector need to replace for specific cable. | Device | Group A : defibrillator ECG to patchy-type ECG |
Primary outcome
Time from 12-lead ECG device application starting to sending ECG result to hospital.
Time frame: through study completion, an average of 2 month
comparison of interval from the start of 12-lead ECG device application to complete of ECG result sending
1 secondary outcome
Usability of patchy-type wireless ECG device.
Time frame: survey collecting through study completion an average of 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Derived from this study: PubMed 36099010Yoo S, Chang H, Kim T, Yoon H, Hwang SY, Shin TG, Sim MS, Jo IJ, Choi JH, Cha WC. Intervention in the Timeliness of Two Electrocardiography Types for Patients in the Emergency Department With Chest Pain: Randomized Controlled Trial. Interact J Med Res. 2022 Sep 13;11(2):e36335. doi: 10.2196/36335.
- Derived from this study: PubMed 33792550Yoon S, Kim T, Roh T, Chang H, Hwang SY, Yoon H, Shin TG, Sim MS, Jo IJ, Cha WC. Twelve-Lead Electrocardiogram Acquisition With a Patchy-Type Wireless Device in Ambulance Transport: Simulation-Based Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Apr 1;9(4):e24142. doi: 10.2196/24142.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
tearim kim, doctoral principal investigator
samsumg medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patchy-type wireless ECG and defibrillator ECG in people with Chest Pain and Electrocardiography, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from 12-lead ECG device application starting to sending ECG result to hospital. (time frame: through study completion, an average of 2 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04114760, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.