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Performance Testing of the Modified Electrocardiogram Lead Placement

19 luglio 2026 aggiornato da: Hansu Bae

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

84

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Dongkyu Lee, MD. Ph.D
  • Numero di telefono: 080-10-6431-4217
  • Email: entopic@naver.com

Luoghi di studio

  • Corea del Sud
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Corea del Sud, 10326
        • Reclutamento
        • Dongguk University Il-san Hospital
        • Contatto:
        • Contatto:
      • Goyang-si, Gyeonggi-do, Corea del Sud, 10326
        • Non ancora reclutamento
        • Dongguk University Ilsan Hospital
        • Contatto:
          • Hansu Assistant professor, MD.
          • Numero di telefono: 080-10-6326-1641
          • Email: hsbae81@gmail.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients who do not consent to the study.
  • Patients with implanted pacemakers.
  • Patients with a history of heart or lung surgery.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: All Participants
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
Dispositivo: Standard
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."
Altri nomi:
  • mSC2
  • mTC2
Dispositivo: mSC2
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.
Dispositivo: mTC2
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of participants for whom each modified Lead II configuration demonstrates superior visual similarity to the Standard Lead II
Lasso di tempo: 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.
Periprocedural

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of participants for whom each right-side modified Lead II configuration demonstrates superior visual similarity to the Standard Lead II
Lasso di tempo: Periprocedural
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.
Periprocedural
Mean difference in ST segment amplitude between modified Temple-Chest Lead II (mTC2) and Standard Lead II
Lasso di tempo: Periprocedural
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.
Periprocedural
Mean difference in ST segment amplitude between modified Sternum-Chest Lead II (mSC2) and Standard Lead II
Lasso di tempo: Periprocedural
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.
Periprocedural

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hansu Bae

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

25 febbraio 2026

Completamento primario (Stimato)

17 dicembre 2026

Completamento dello studio (Stimato)

5 novembre 2027

Date di iscrizione allo studio

Primo inviato

15 novembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

19 luglio 2026

Primo Inserito (Effettivo)

22 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • DUIH IRB 2025-12-018

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

No plan to share individual participant data to protect participant privacy.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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