Monitoring During AnesthesiaNCT07719777
Performance Testing of the Modified Electrocardiogram Lead Placement
A study testing Standard, mSC2 and mTC2 in people with Monitoring During Anesthesia, run by Hansu Bae at 2 sites in South Korea.
Trial summary
During general anesthesia for surgery, doctors use an electrocardiogram (ECG)-a simple heart monitor-to check for problems like poor blood flow to the heart or irregular heartbeats. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Monitoring During Anesthesia
- What is being tested?
- Standard, mSC2 and mTC2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 25 Feb 2026to 5 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female patients aged 19 to 65 years scheduled for surgery under general anesthesia.
- Patients scheduled for surgery in areas that do not affect ECG electrode placement (e.g., abdomen, head, face, lower limbs).
- Patients with normal or abnormal ST segment changes confirmed on preoperative ECG.
Who cannot join
- Patients who do not consent to the study.
- Patients with implanted pacemakers.
- Patients with a history of heart or lung surgery.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Dongguk University Il-san Hospital
Goyang-si, Gyeonggi-do, 10326
Hansu Bae, M.D., 010-6326-1641, hsbae81@gmail.com
Lee, M.D., Ph.D, 010-6431-4217, entopic@naver.com
- Not yet recruiting
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 10326
Hansu Assistant professor, MD., 080-10-6326-1641, hsbae81@gmail.com
About this study
Official title: Performance Testing of the Modified Electrocardiogram Lead Placement in Patients Undergoing General Anesthesia
During general anesthesia for surgery, doctors use an electrocardiogram (ECG)-a simple heart monitor-to check for problems like poor blood flow to the heart or irregular heartbeats. Normally, ECG stickers (called electrodes) go on both shoulders and the left side of the belly, right outside the heart area, to get clear readings.
But for shoulder surgery, these spots are in the way of the operation, so doctors often place them elsewhere, like on the breastbone instead of the shoulder. This can give fuzzy or wrong results, missing key changes in the patient's heart-good or bad-during surgery.
To fix this and better watch heart health in shoulder surgery patients, this study tests different ECG sticker spots: the usual ones, the common backup (like on the breastbone), and a new idea-placing them near both temples. Researchers hope to find which setup gives the most accurate heart readings to keep patients safer.
Read the detailed description
Background and Rationale Electrocardiogram (ECG) monitoring is essential during general anesthesia to assess heart rate, arrhythmias, and myocardial ischemia, alongside blood pressure. Standard Lead II, derived from limb leads placed on the torso (both clavicles below and left anterior superior iliac spine, outside the heart boundary), aligns best with the heart's electrical axis for accurate rhythm and ischemia detection. However, in shoulder surgeries like arthroscopic rotator cuff repair, surgical incisions overlap these sites, forcing electrode relocation (e.g., to the sternum instead of the shoulder). This inward shift distorts ECG signals, potentially missing normal or abnormal heart changes during surgery. To address this, modified Lead II placements are needed for reliable cardiac surveillance in shoulder surgery patients.
Study Overview This prospective, single-group interventional study evaluates the performance of two modified ECG Lead II configurations compared to the standard during general anesthesia for non-shoulder surgeries (to simulate placement feasibility). The modifications test alternative sites for the left shoulder electrode: sternum center (modified Sternum-Chest Lead II, mSC2) versus temple (modified Temple-Chest Lead II, mTC2). Left-side versions are assessed post-induction in supine position; right-side versions post-surgery. Outcomes focus on ST segment morphology similarity (visual and quantitative) to ensure modified leads maintain diagnostic accuracy without artifacts.
Methods Summary Eligible adults (19-65 years) scheduled for general anesthesia in non-shoulder sites undergo standard monitoring (ECG, NIBP, SpO2) per institutional protocols. After induction and hemodynamic stabilization, three ECG configurations are recorded simultaneously using Vital Recorder software (VitalDB, Republic of Korea) for at least 10 noise-free waves: (1) Standard Lead II; (2) Left mSC2 (sternum, right shoulder, left iliac spine); (3) Left mTC2 (left temple, right shoulder, left iliac spine). Post-surgery, right-side mSC2 and mTC2 are added. Recordings capture preoperative ST segment status (normal/abnormal). Blinded assessors (two researchers, third for ties) evaluate ST similarity visually; quantitative area differences use R/RStudio.
Statistical Considerations Sample size (n=84, 10% dropout) is calculated via McNemar test for paired comparisons, stratified by ST status (normal: 38 pairs; abnormal: 46 pairs), yielding 80% power at $\alpha=0.05$ based on pilot data. Analysis: Stratified McNemar for agreement; R for area differences.
Safety and Ethics Modifications involve brief additional recordings with no added risk beyond standard care. IRB-approved (Dongguk University Ilsan Hospital); informed consent obtained. Data anonymized (case numbers); stored securely for 3 years per regulations.
- Conditions
- Monitoring During Anesthesia
- Being tested
- Standard, mSC2, mTC2
- Keywords
- ECG Lead Placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StandardDevice
Also called mSC2, mTC2
Standard ECG Lead II monitoring: Three electrodes placed on both clavicles below and left anterior superior iliac spine (outside heart boundary). Recorded simultaneously post-induction for at least 10 noise-free waves using Vital Recorder software to establish baseline ST segment morphology during general anesthesia."
mSC2Device
Modified Sternum-Chest Lead II ECG (mSC2): Electrode relocated to sternum center (replacing left shoulder), with right shoulder and left anterior superior iliac spine. Left-side version recorded post-induction; right-side post-surgery. Assesses ST segment similarity to standard for accurate ischemia detection in anesthesia.
mTC2Device
Modified Temple-Chest Lead II ECG (mTC2): Electrode relocated near temple (replacing left shoulder), with right shoulder and left anterior superior iliac spine. Left-side version recorded post-induction; right-side post-surgery. Evaluates ST segment morphology match to standard to enhance cardiac monitoring reliability.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | All enrolled patients (n=84) undergoing general anesthesia without restrictions on ECG lead placement receive simultaneous ECG monitoring with three lead configurations: standard Lead II (baseline), left-side modified sternum-chest Lead II (mSC2), and left-side modified temple-chest Lead II (mTC2) post-induction. Right-side versions are added post-surgery. This single arm tests ST segment similarity across methods to improve intraoperative cardiac monitoring accuracy Receives: Device: Standard; Device: mSC2; Device: mTC2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants for whom each modified Lead II configuration demonstrates superior visual similarity to the Standard Lead II
This measure evaluates and compares which of the two modified Lead II configurations (Left modified Temple-Chest Lead II [Lt-mTC2] vs. Left modified Sternum-Chest Lead II [Lt-mSC2]) aligns more accurately with the Standard Lead II. To ensure objectivity, two blinded researchers will independently compare the ECG waveform shapes and determine which modified lead shows superior visual similarity to the Standard Lead II. In cases of disagreement or tie, a third researcher will re-evaluate the waveforms for the final decision. Evaluators will be strictly blinded to the identity of the specific leads being assessed.
Measured: Periprocedural
Secondary outcomes (3)
Percentage of participants for whom each right-side modified Lead II configuration demonstrates superior visual similarity to the Standard Lead II
This measure evaluates and compares which of the two right-side modified Lead II configurations (Right modified Temple-Chest Lead II [Rt-mTC2] vs. Right modified Sternum-Chest Lead II [Rt-mSC2]) aligns more accurately with the Standard Lead II post-surgery. Two blinded researchers will independently compare the ECG waveform shapes and determine which right-side modified lead shows superior visual similarity to the Standard Lead II. In cases of disagreement or tie, a third researcher will re-evaluate the waveforms for the final decision. Evaluators will be strictly blinded to the identity of the specific leads.
Measured: Periprocedural
Mean difference in ST segment amplitude between modified Temple-Chest Lead II (mTC2) and Standard Lead II
The quantitative difference in ST segment amplitude (measured in millimeters or millivolts) will be compared between the mTC2 configuration and the Standard Lead II. Waveform data will be processed using R and RStudio programs to calculate the absolute amplitude differences. A paired t-test will be performed to analyze the statistical agreement and determine if significant differences exist between the two leads.
Measured: Periprocedural
Mean difference in ST segment amplitude between modified Sternum-Chest Lead II (mSC2) and Standard Lead II
The quantitative difference in ST segment amplitude (measured in millimeters or millivolts) will be compared between the mSC2 configuration and the Standard Lead II. Waveform data will be processed using R and RStudio programs to calculate the absolute amplitude differences. A paired t-test will be performed to analyze the statistical agreement and determine if significant differences exist between the two leads.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start25 Feb 2026
- Primary completion17 Dec 2026 (estimated)
- Study completion5 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monitoring During AnesthesiaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansu Bae
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hansu Bae, Dongguk University International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719777
- Sponsor's protocol ID
- DUIH IRB 2025-12-018
- Status last verified
- Jul 2026
- First submitted
- 15 Nov 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data to protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Testing of the Modified Electrocardiogram Lead Placement in Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT07719777
- Acronym / sponsor ID
- DUIH IRB 2025-12-018
- Conditions
- Monitoring During Anesthesia
- Keywords
- ECG Lead Placement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hansu BaeUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 17 Dec 2026 (estimated)
- Study completion
- 5 Nov 2027 (estimated)
- First posted
- 22 Jul 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.
During general anesthesia for surgery, doctors use an electrocardiogram (ECG)-a simple heart monitor-to check for problems like poor blood flow to the heart or irregular heartbeats. Normally, ECG stickers (called electrodes) go on both shoulders and the left side of the belly, right outside the heart area, to get clear readings.
But for shoulder surgery, these spots are in the way of the operation, so doctors often place them elsewhere, like on the breastbone instead of the shoulder. This can give fuzzy or wrong results, missing key changes in the patient's heart-good or bad-during surgery.
To fix this and better watch heart health in shoulder surgery patients, this study tests different ECG sticker spots: the usual ones, the common backup (like on the breastbone), and a new idea-placing them near both temples. Researchers hope to find which setup gives the most accurate heart readings to keep patients safer.
Detailed description
Background and Rationale Electrocardiogram (ECG) monitoring is essential during general anesthesia to assess heart rate, arrhythmias, and myocardial ischemia, alongside blood pressure. Standard Lead II, derived from limb leads placed on the torso (both clavicles below and left anterior superior iliac spine, outside the heart boundary), aligns best with the heart's electrical axis for accurate rhythm and ischemia detection. However, in shoulder surgeries like arthroscopic rotator cuff repair, surgical incisions overlap these sites, forcing electrode relocation (e.g., to the sternum instead of the shoulder). This inward shift distorts ECG signals, potentially missing normal or abnormal heart changes during surgery. To address this, modified Lead II placements are needed for reliable cardiac surveillance in shoulder surgery patients.
Study Overview This prospective, single-group interventional study evaluates the performance of two modified ECG Lead II configurations compared to the standard during general anesthesia for non-shoulder surgeries (to simulate placement feasibility). The modifications test alternative sites for the left shoulder electrode: sternum center (modified Sternum-Chest Lead II, mSC2) versus temple (modified Temple-Chest Lead II, mTC2). Left-side versions are assessed post-induction in supine position; right-side versions post-surgery. Outcomes focus on ST segment morphology similarity (visual and quantitative) to ensure modified leads maintain diagnostic accuracy without artifacts.
Methods Summary Eligible adults (19-65 years) scheduled for general anesthesia in non-shoulder sites undergo standard monitoring (ECG, NIBP, SpO2) per institutional protocols. After induction and hemodynamic stabilization, three ECG configurations are recorded simultaneously using Vital Recorder software (VitalDB, Republic of Korea) for at least 10 noise-free waves: (1) Standard Lead II; (2) Left mSC2 (sternum, right shoulder, left iliac spine); (3) Left mTC2 (left temple, right shoulder, left iliac spine). Post-surgery, right-side mSC2 and mTC2 are added. Recordings capture preoperative ST segment status (normal/abnormal). Blinded assessors (two researchers, third for ties) evaluate ST similarity visually; quantitative area differences use R/RStudio.
Statistical Considerations Sample size (n=84, 10% dropout) is calculated via McNemar test for paired comparisons, stratified by ST status (normal: 38 pairs; abnormal: 46 pairs), yielding 80% power at $\alpha=0.05$ based on pilot data. Analysis: Stratified McNemar for agreement; R for area differences.
Safety and Ethics Modifications involve brief additional recordings with no added risk beyond standard care. IRB-approved (Dongguk University Ilsan Hospital); informed consent obtained. Data anonymized (case numbers); stored securely for 3 years per regulations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Device: Standard, Device: mSC2, Device: mTC2All enrolled patients (n=84) undergoing general anesthesia without restrictions on ECG lead placement receive simultaneous ECG monitoring with three lead configurations: standard Lead II (baseline), left-side modified sternum-chest Lead II (mSC2), and left-side modified temple-chest Lead II (mTC2) post-induction. Right-side versions are added post-surgery. This single arm tests ST segment similarity across methods to improve intraoperative cardiac monitoring accuracy |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult male and female patients aged 19 to 65 years scheduled for surgery under general anesthesia.
- Patients scheduled for surgery in areas that do not affect ECG electrode placement (e.g., abdomen, head, face, lower limbs).
- Patients with normal or abnormal ST segment changes confirmed on preoperative ECG.
Key exclusion criteria (3 listed)
- Patients who do not consent to the study.
- Patients with implanted pacemakers.
- Patients with a history of heart or lung surgery.
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 |
|---|---|---|
| StandardAlso: mSC2, mTC2Standard ECG Lead II monitoring: Three electrodes placed on both clavicles below and left anterior superior iliac spine (outside heart boundary). Recorded simultaneously post-induction for at least 10 noise-free waves using Vital Recorder software to establish baseline ST segment morphology during general anesthesia." | Device | All Participants |
| mSC2Modified Sternum-Chest Lead II ECG (mSC2): Electrode relocated to sternum center (replacing left shoulder), with right shoulder and left anterior superior iliac spine. Left-side version recorded post-induction; right-side post-surgery. Assesses ST segment similarity to standard for accurate ischemia detection in anesthesia. | Device | All Participants |
| mTC2Modified Temple-Chest Lead II ECG (mTC2): Electrode relocated near temple (replacing left shoulder), with right shoulder and left anterior superior iliac spine. Left-side version recorded post-induction; right-side post-surgery. Evaluates ST segment morphology match to standard to enhance cardiac monitoring reliability. | Device | All Participants |
Primary outcome
Percentage of participants for whom each modified Lead II configuration demonstrates superior visual similarity to the Standard Lead II
Time frame: Periprocedural
This measure evaluates and compares which of the two modified Lead II configurations (Left modified Temple-Chest Lead II [Lt-mTC2] vs. Left modified Sternum-Chest Lead II [Lt-mSC2]) aligns more accurately with the Standard Lead II. To ensure objectivity, two blinded researchers will independently compare the ECG waveform shapes and determine which modified lead shows superior visual similarity to the Standard Lead II. In cases of disagreement or tie, a third researcher will re-evaluate the waveforms for the final decision. Evaluators will be strictly blinded to the identity of the specific leads being assessed.
3 secondary outcomes
Percentage of participants for whom each right-side modified Lead II configuration demonstrates superior visual similarity to the Standard Lead II
Time frame: Periprocedural
Mean difference in ST segment amplitude between modified Temple-Chest Lead II (mTC2) and Standard Lead II
Time frame: Periprocedural
Mean difference in ST segment amplitude between modified Sternum-Chest Lead II (mSC2) and Standard Lead II
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No. No plan to share individual participant data to protect participant privacy.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard, mSC2 and mTC2 in people with Monitoring During Anesthesia, run by Hansu Bae at 2 sites in South Korea.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hansu Bae, MD (080-10-6326-1641, hsbae81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants for whom each modified Lead II configuration demonstrates superior visual similarity to the Standard Lead II (time frame: Periprocedural). 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 22 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.