Twelve Leads Electrocardiographic Expressions at Different Body Positioning

October 18, 2024 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
Electrical conduction in the heart produces a heartbeat; electrical signals are sent to the heart muscle upon each contraction, causing the heart to pump blood. These electrical impulses are recorded by an electrocardiogram (ECG), which makes it possible to evaluate electrical conduction and cardiac rhythm. ECG is a non-invasive technique used to assess pacemaker function and perioperative heart health. Ten electrodes are used in the 12-lead ECG, the gold standard for diagnosing cardiac illness and anatomy, to record the electrical activity of the heart from various perspectives. With wireless data transmission to the cloud, this technology is now included into emergency and ambulance situations, streamlining processes and improving signal quality. The purpose of this observational study is to examine 12-lead electrocardiogram data for better clinical application and diagnosis.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The heartbeat is a result of electrical conduction in the heart. The heart's contractions release electrical signals that trigger the heart muscle to pump blood to the lungs and the rest of the body. An electrocardiogram (ECG) records these electrical signals from each heartbeat, allowing for the observation of heart rhythm and the assessment of any abnormalities in electrical conduction. The ECG is a non-invasive monitoring tool used for evaluating heart health throughout the perioperative period and for checking the function of pacemakers. By analyzing the shape, size, and time intervals of these waveforms, ECGs provide visual representations that help healthcare professionals assess conditions related to heart valve diseases.

The 12-lead ECG is considered the gold standard for evaluating cardiac structure and diagnosing various heart conditions. This system consists of twelve leads created from ten electrodes, recording the heart rates electrical activity from different angles in three-dimensional space to understand the condition of various heart regions. Currently, 12-lead ECG machines are widely used in emergency and ambulance settings. They often incorporate integrated electrode patches that replace the traditional ten individual electrode patches, significantly simplifying the process and reducing errors. This integration improves signal transmission and quality compared to traditional ECG leads. Data is transmitted wirelessly, paired with mobile device software, and sent to the cloud to support diagnostic reports.

This study is an observational research project aimed at establishing and analyzing 12-lead ECG data. The goal is to utilize this data for more in-depth diagnostics and to observe its differences and clinical applications.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Sanmin Dist
      • Kaohsiung, Sanmin Dist, Taiwan, 80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants without diagnosed arrhythmia, ischemic heart disease, congestive heart failure or pending for all kinds of heart surgery.

Description

Inclusion Criteria:

  • Adults 18~65 years of age
  • Fluent in either Taiwanese/Chinese/English.

Exclusion Criteria:

  • Pregnancy
  • Refusal to give informed consent
  • Candidate for coronary bypass surgery or valves surgery or other cardiac surgery
  • Participants with diagnosed arrhythmia, ischemic heart disease or congestive heart failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ECG change related to position
Time Frame: through study completion, an average of 30 minutes.
ECG ST segment elevation or depression might be attributed to varying body postures. The ST segments' change to baseline will be compared by the investigators.
through study completion, an average of 30 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Study Director: Tzu-Ying Li, Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 31, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 25, 2024

First Submitted That Met QC Criteria

October 18, 2024

First Posted (Actual)

October 21, 2024

Study Record Updates

Last Update Posted (Actual)

October 21, 2024

Last Update Submitted That Met QC Criteria

October 18, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KMUHIRB-E(I)-20240272

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Statistical Analysis Plan can be shared

IPD Sharing Time Frame

Beginning 3 months and ending 1 year after the publication of results

IPD Sharing Access Criteria

Researchers with formal inquiry will be able to access it.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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