Electrocardiographic Signal AcquisitionNCT07787104
Effects of Electrode Preparation on 12-Lead ECG R-Wave Amplitudes
A study testing Electrode Preparation in people with Electrocardiographic Signal Acquisition, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Electrocardiographic Signal Acquisition
- What is being tested?
- Electrode Preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jan 2023to 13 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult volunteers aged 18 to 65 years.
- Ability and willingness to provide written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Emergency Medicine
Tokat Province, Tokat Province, 60100
About this study
Official title: Comparison of Electrode Preparation Methods for ECG Signal Quality in Healthy Adults
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.
Read the 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.
- Conditions
- Electrocardiographic Signal Acquisition
- Being tested
- Electrode Preparation
- Keywords
- Electrocardiography, ECG amplitude, Electrode preparation, Skin-electrode interface, Isopropyl alcohol, Electroconductive gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrode PreparationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Electrode Preparation Methods | Experimental | All participants underwent four consecutive standard 12-lead ECG recordings using four electrode preparation conditions: dry skin, drinking-quality tap water, 70% isopropyl alcohol, and electroconductive gel. The four conditions were applied in a fixed sequence, with new disposable Ag/AgCl electrodes used for each recording. Receives: Other: Electrode Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
R-Wave Amplitude Across Electrode Preparation Methods
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).
Measured: During the study visit, across four consecutive ECG recordings approximately 1 minute apart, assessed over approximately 7 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start13 Jan 2023
- Primary completion13 Jan 2024
- Study completion13 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrocardiographic Signal AcquisitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Hasgul, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787104
- Sponsor's protocol ID
- ECG-2023-001
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Electrode Preparation Methods for ECG Signal Quality in Healthy Adults
- ClinicalTrials.gov ID
- NCT07787104
- Acronym / sponsor ID
- ECG-2023-001
- Conditions
- Electrocardiographic Signal Acquisition
- Keywords
- Electrocardiography, ECG amplitude, Electrode preparation, Skin-electrode interface, Isopropyl alcohol, Electroconductive gel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 13 Jan 2024 (actual)
- Study completion
- 13 Jan 2024 (actual)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Electrode Preparation Methods | Experimental | Other: Electrode PreparationAll participants underwent four consecutive standard 12-lead ECG recordings using four electrode preparation conditions: dry skin, drinking-quality tap water, 70% isopropyl alcohol, and electroconductive gel. The four conditions were applied in a fixed sequence, with new disposable Ag/AgCl electrodes used for each recording. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adult volunteers aged 18 to 65 years.
- Ability and willingness to provide written informed consent.
Key exclusion criteria (6 listed)
- Known cardiovascular disease.
- Cardiac arrhythmia.
- Implanted cardiac device.
- Dermatological disorder affecting electrode placement sites.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrode PreparationParticipants 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. | Other | Electrode Preparation Methods |
Primary outcome
R-Wave Amplitude Across Electrode Preparation Methods
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrode Preparation in people with Electrocardiographic Signal Acquisition, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R-Wave Amplitude Across Electrode Preparation Methods (time frame: During the study visit, across four consecutive ECG recordings approximately 1 minute apart, assessed over approximately 7 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.