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Effects of Electrode Preparation on 12-Lead ECG R-Wave Amplitudes

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07787104
Enrollment
96
Registered
2026-08-26
Start date
2023-01-13
Completion date
2024-01-13
Last updated
2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electrocardiographic Signal Acquisition

Keywords

Electrocardiography, ECG amplitude, Electrode preparation, Skin-electrode interface, Isopropyl alcohol, Electroconductive gel

Brief summary

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.

Detailed description

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.

Interventions

OTHERElectrode Preparation

Participants underwent four consecutive standard 12-lead ECG recordings under four electrode preparation conditions: dry skin (no preparation), drinking-quality tap water, 70% isopropyl alcohol, and commercial electroconductive gel. The conditions were applied in a fixed sequence. New disposable Ag/AgCl electrodes were used for each recording, and the skin was allowed to dry completely before the subsequent preparation method was applied.

Sponsors

Tokat Gaziosmanpasa University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Masking description

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

Intervention model description

Each participant underwent four consecutive 12-lead ECG recordings using dry skin, drinking-quality tap water, 70% isopropyl alcohol, and electroconductive gel in a fixed sequence. All participants received all four interventions.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
R-Wave Amplitude Across Electrode Preparation MethodsDuring 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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026