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

NCT ID: NCT07277374

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-06
• Study Completion Date: 2024-06-06

Brief Summary

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.

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.

Conditions

Healthy Volunteer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Volunteer ECG Group

Participants underwent standard 12-lead ECG and torso-based 6-lead ECG in a single session for comparative interval analysis.

Torso-Based 6-Lead ECG Recording

Intervention Type: DEVICE

Non-invasive ECG measurement with torso electrode placement for comparison with standard 12-lead ECG.

Interventions

Torso-Based 6-Lead ECG Recording

Non-invasive ECG measurement with torso electrode placement for comparison with standard 12-lead ECG.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Haydarpasa Numune Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sinem Dogruyol

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Haydarpaşa Numune Training and Research Hospital - Emergency Medicine Department

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HNH-KAEK 2023/KK/193

Identifier Type: -

Identifier Source: org_study_id