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

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.

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