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Validation testing of the spacelabs PC2 ST-segment analyzer

M J London1, L D Ahlstrom

  • 1Department of Anesthesiology, University of Colorado Health Sciences Center, Denver, USA.

Journal of Cardiothoracic and Vascular Anesthesia
|December 1, 1995
PubMed
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This study developed a new electrocardiogram (ECG) simulator protocol to test ST-segment analyzers. The protocol revealed that while most ECG readings were accurate, prolonged QRS durations caused issues, suggesting visual confirmation is advisable.

Area of Science:

  • Cardiology
  • Biomedical Engineering
  • Critical Care Medicine

Background:

  • Perioperative myocardial ischemia detected by electrocardiography (ECG) is a risk factor for myocardial infarction.
  • ST-segment analyzers and hemodynamic monitors are crucial for on-line detection in critical care.
  • Established performance and accuracy standards for these devices are lacking.

Purpose of the Study:

  • To develop and validate a testing protocol for ST-segment analyzers using an ECG simulator.
  • To assess the accuracy and performance of ST-segment analyzers under various simulated ECG conditions.
  • To establish standards for evaluating the reliability of perioperative ischemia detection devices.

Main Methods:

  • A laboratory bench study utilizing a custom digital ECG waveform simulator.

Related Experiment Videos

  • Manipulation of ST-segment displacement, QRS duration, and P wave presence across seven QRS shapes.
  • Testing of a PC2 Bedside Monitor with 148 measurements per session to evaluate ST-segment value accuracy and reference point placement.

    • Main Results:

    • The ECG simulator accurately reproduced ST-segment deviations within +/- 0.25 mm for 98% of tests with normal QRS duration and proper isoelectric point placement.
    • Subtle J-point marker placement errors were observed in all QRS shapes, but typically did not affect ST-segment values.
    • Erroneous ST-segment values occurred in two QRS shapes, one potentially due to prolonged QRS duration (120 msec) and the other in normal duration complexes (24%).

    Conclusions:

    • Bench results indicate that visual confirmation of ST-segment analyzer values may be prudent in clinical settings.
    • Most ECG complexes with normal conduction and a P wave are likely analyzed accurately.
    • Devices analyzing ECGs with prolonged QRS duration require careful evaluation, and the simulator protocol aids in ST-segment analyzer development.