NCT07277374

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Haydarpasa Numune Training and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Torso-Based 6-Lead ECG Recording	Non-invasive ECG measurement with torso electrode placement for comparison with standard 12-lead ECG.

Timeline

• Start date: 2023-12-06
• Primary completion: 2024-03-06
• Completion: 2024-06-06
• First posted: 2025-12-11
• Last updated: 2025-12-11

Locations

1 site across 1 country: Turkey (Türkiye)