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临床试验/NCT07787104
NCT07787104已完成不适用

Comparison of Electrode Preparation Methods for ECG Signal Quality in Healthy Adults

Tokat Gaziosmanpasa University0 个研究点目标入组 96 人开始时间: 2023年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
主要终点
R-Wave Amplitude Across Electrode Preparation Methods

研究概览

简要总结

This study evaluated whether different methods of preparing the skin before a standard 12-lead electrocardiogram (ECG) affect the recorded ECG wave amplitudes. Healthy adult volunteers underwent four consecutive ECG recordings using dry skin, drinking-quality tap water, 70% isopropyl alcohol, and electroconductive gel as electrode preparation methods. The study compared R-wave amplitudes obtained with these four methods and also evaluated whether sex and body mass index (BMI) were associated with differences in ECG amplitude.

详细描述

This prospective, within-subject comparative study was conducted in healthy adult volunteers. The study was designed to evaluate the effects of different electrode preparation methods on R-wave amplitudes recorded during standard 12-lead electrocardiography (ECG).

Each participant underwent four consecutive 12-lead ECG recordings under standardized conditions. The electrode preparation methods were dry skin, drinking-quality tap water, 70% isopropyl alcohol, and commercial electroconductive gel. New disposable Ag/AgCl electrodes were used for each recording. Electrode positions were maintained throughout the study, and approximately one minute elapsed between consecutive recordings.

R-wave amplitudes were measured in all 12 ECG leads after completion of data collection. ECG recordings were anonymized before measurement, and the investigators performing the measurements were blinded to the electrode preparation method. In addition to comparing R-wave amplitudes among the four preparation methods, the study evaluated the associations of sex and body mass index with ECG amplitude and assessed agreement between 70% isopropyl alcohol and electroconductive gel.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

盲法说明

ECG recordings were anonymized before R-wave amplitude measurement. The outcome assessors were blinded to the electrode preparation method used for each recording.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adult volunteers aged 18 to 65 years.
  • Ability and willingness to provide written informed consent.

排除标准

  • Known cardiovascular disease.
  • Cardiac arrhythmia.
  • Implanted cardiac device.
  • Dermatological disorder affecting electrode placement sites.
  • Pregnancy.
  • Any condition potentially interfering with standard 12-lead ECG acquisition.

结局指标

主要结局

R-Wave Amplitude Across Electrode Preparation Methods

时间窗: During the study visit, across four consecutive ECG recordings approximately 1 minute apart, assessed over approximately 7 minutes.

R-wave amplitude was measured in all 12 ECG leads (I, II, III, aVR, aVL, aVF, and V1-V6) under each of the four electrode preparation conditions: dry skin, drinking-quality tap water, 70% isopropyl alcohol, and electroconductive gel. R-wave amplitude was defined as the vertical distance from the isoelectric baseline to the peak of the R wave and was measured in millimeters (mm).

次要结局

未报告次要终点

研究者

发起方
Tokat Gaziosmanpasa University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Burak Hasgul

Assistant Professor of Emergency Medicine

Tokat Gaziosmanpasa University

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