Performance Testing of the Modified Electrocardiogram Lead Placement in Patients Undergoing General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Percentage of participants for whom each modified Lead II configuration demonstrates superior visual similarity to the Standard Lead II
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
In the evaluation process of the primary outcome, the ST segment morphology of the original Lead II is compared with the ST segment morphology of the ECG waveform measured by placing the lead at the left temple (mTCII) and the waveform measured by placing the lead at the sternum (mSCII). At this time, blinding is applied to the mTCII and mSCII waveforms, allowing the three evaluators to perform the assessment without knowing which lead the ECG waveform was recorded from.
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients who do not consent to the study.
- •Patients with implanted pacemakers.
- •Patients with a history of heart or lung surgery.
结局指标
主要结局
Percentage of participants for whom each modified Lead II configuration demonstrates superior visual similarity to the Standard Lead II
时间窗: 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.
次要结局
- Percentage of participants for whom each right-side modified Lead II configuration demonstrates superior visual similarity to the Standard Lead II(Periprocedural)
- Mean difference in ST segment amplitude between modified Temple-Chest Lead II (mTC2) and Standard Lead II(Periprocedural)
- Mean difference in ST segment amplitude between modified Sternum-Chest Lead II (mSC2) and Standard Lead II(Periprocedural)
研究者
Hansu Bae
Assistant Professor
Dongguk University International Hospital