Healthy Volunteer
Conditions
Keywords
Electrocardiography, 6-lead ECG, 12-lead ECG, Torso ECG, ECG comparison
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.
Interventions
DEVICETorso-Based 6-Lead ECG Recording
Non-invasive ECG measurement with torso electrode placement for comparison with standard 12-lead ECG.
Sponsors
Haydarpasa Numune Training and Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PR Interval Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG) | Single-session baseline ECG recording. | 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. |
| QRS Duration Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG) | Single-session baseline ECG recording. | Mean difference in QRS duration between torso-derived six-lead ECG and standard 12-lead ECG recordings obtained during the same resting session |
| QT Interval Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG) | Single-session baseline ECG recording | Mean difference in QT interval between torso-derived six-lead ECG and standard 12-lead ECG recordings obtained during the same resting session. |
| Heart Rate (HR) Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG) | Single-session baseline ECG recording. | Mean difference in heart rate (HR) between torso-derived six-lead ECG and standard 12-lead ECG recordings obtained during the same resting session. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agreement Between Torso-Derived 6-Lead Electrocardiogram (ECG) and Standard 12-Lead Electrocardiogram (ECG) Measurements | Single-session recording (baseline only) | 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) |
Countries
Turkey (Türkiye)
Outcome results
None listed