Comparison of a Torso-Based Derived 6-Lead Electrocardiogram (ECG) Device With Standard 12-Lead Electrocardiogram (ECG) in Healthy Volunteers (T-ECG)

Comparison of 6-Lead Electrocardiogram (ECG) Device Data With Standard 12-Lead Electrocardiogram (ECG) Data in Individuals With Different Anthropometric Characteristics

This study aims to compare electrocardiographic interval measurements obtained from a torso-placed six-lead electrocardiogram (ECG) device (torso-derived ECG; T-ECG) with those obtained from a standard 12-lead electrocardiogram (ECG) in healthy adult volunteers. The torso-derived device synthesizes limb-lead signals using electrodes positioned on the thorax, potentially allowing for faster and more practical ECG acquisition in emergency department settings, operating rooms, and prehospital environments.

A total of 24 participants undergo both standard 12-lead ECG recording and torso-derived 6-lead ECG recording during the same study session. Heart rate (HR), PR interval, QRS duration, QT interval, and corrected QT (QTc) values are analyzed using Bland-Altman agreement analysis and correlation testing. The study also evaluates whether anthropometric characteristics-including body mass index (BMI)-influence the compatibility and agreement between the two measurement systems.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Device: Torso-Based 6-Lead ECG Recording

Detailed Description

This observational, single-center clinical study evaluates the agreement between a torso-based derived six-lead electrocardiogram (ECG) system and a standard 12-lead electrocardiogram (ECG) in healthy adult volunteers. The study is conducted at Haydarpasa Numune Training and Research Hospital following ethics committee approval (Approval No: 2023/193). Volunteers aged 18 to 65 years without known cardiac disease are enrolled.

Each participant undergoes one standard 12-lead ECG recording followed by a torso-based six-lead ECG recording under identical resting conditions. Electrocardiographic measurements include heart rate (HR), RR interval, PR interval, QRS duration, QT interval, and corrected QT (QTc). Anthropometric characteristics-body weight, height, and body mass index (BMI)-are collected to assess whether body composition influences measurement consistency between the two systems.

Primary analysis includes Bland-Altman agreement statistics and correlation testing between ECG modalities. No drug administration, invasive procedure, randomization, or therapeutic intervention is applied. The study involves minimal risk and is limited to non-invasive surface ECG acquisition.

The expected clinical significance is that, if the torso-based ECG demonstrates measurement compatibility with the standard 12-lead ECG, simplified electrode placement may enable faster ECG acquisition in emergency departments, prehospital evaluations, and clinical scenarios in which limb lead placement is impractical.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34668
    • Haydarpaşa Numune Training and Research Hospital - Emergency Medicine Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of healthy adult volunteers without known cardiovascular disease. All participants undergo both standard 12-lead electrocardiogram (ECG) recording and torso-derived 6-lead electrocardiogram (ECG) recording during a single study session. Participants are screened prior to inclusion to ensure the absence of baseline arrhythmia, ischemia, conduction delay, or structural heart disease.

Description

Inclusion Criteria:

Age between 18 and 65 years

No known cardiovascular disease

No arrhythmia, conduction disorder, or ischemic electrocardiogram (ECG) changes at baseline

Willingness to participate and ability to provide written informed consent

Exclusion Criteria:

Known cardiac disease, including coronary artery disease (CAD), arrhythmia, heart failure, or valvular heart disease

Pacemaker rhythm or baseline abnormal electrocardiogram (ECG) findings

Thoracic deformity or prior thoracic surgery that prevents appropriate electrode placement

Unwillingness to participate or inability to provide informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteer ECG Group; Participants underwent standard 12-lead ECG and torso-based 6-lead ECG in a single session for comparative interval analysis.	Device: Torso-Based 6-Lead ECG Recording; Non-invasive ECG measurement with torso electrode placement for comparison with standard 12-lead ECG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PR Interval Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG)	Mean difference in PR interval between torso-derived six-lead electrocardiogram (ECG) and standard 12-lead ECG recordings obtained during the same resting session. Single-session baseline ECG recording.	Single-session baseline ECG recording.
QRS Duration Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG)	Mean difference in QRS duration between torso-derived six-lead ECG and standard 12-lead ECG recordings obtained during the same resting session	Single-session baseline ECG recording.
QT Interval Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG)	Mean difference in QT interval between torso-derived six-lead ECG and standard 12-lead ECG recordings obtained during the same resting session.	Single-session baseline ECG recording
Heart Rate (HR) Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG)	Mean difference in heart rate (HR) between torso-derived six-lead ECG and standard 12-lead ECG recordings obtained during the same resting session.	Single-session baseline ECG recording.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement Between Torso-Derived 6-Lead Electrocardiogram (ECG) and Standard 12-Lead Electrocardiogram (ECG) Measurements	Description: Comparison of PR interval, QRS duration, QT interval, and heart rate (HR) measurements obtained from torso-derived 6-lead electrocardiogram (ECG) recordings and standard 12-lead electrocardiogram (ECG) recordings to assess measurement concordance. Time Frame: Single-session recording (baseline only)	Single-session recording (baseline only)

Collaborators and Investigators

• Sponsor: Haydarpasa Numune Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2023
• Primary Completion (Actual): March 6, 2024
• Study Completion (Actual): June 6, 2024

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 11, 2025

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Electrocardiography; 12-lead ECG; 6-lead ECG; Torso ECG; ECG comparison
• Other Study ID Numbers: HNH-KAEK 2023/KK/193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because the dataset includes only ECG recordings collected from healthy volunteers, and no identifiable patient-level information is stored or retained. Summary results may be shared in publication form, but raw individual-level data will not be publicly available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No