Comparison of 6-Lead Electrocardiogram (ECG) Device Data With Standard 12-Lead Electrocardiogram (ECG) Data in Individuals With Different Anthropometric Characteristics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- PR Interval Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
PR Interval Agreement Between Torso-Derived and Standard 12-Lead Electrocardiogram (ECG)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Agreement Between Torso-Derived 6-Lead Electrocardiogram (ECG) and Standard 12-Lead Electrocardiogram (ECG) Measurements(Single-session recording (baseline only))
研究者
Sinem Dogruyol
Associate Professor
Haydarpasa Numune Training and Research Hospital