Static testing
Stable, resting conditions in a supine position against the clinical gold standard.
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Clinical data
A comprehensive clinical evaluation of the V-CHEK cuffless blood pressure monitoring device in Bengaluru, India.
Study overview
V-CHEK was evaluated at the Sri Jayadeva Institute of Cardiovascular Sciences and Research to assess the accuracy and reliability of blood pressure, heart rate and SpO₂ measurement against the mercury-based sphygmomanometer and hospital-grade pulse oximeters.
Demographics
The trial was designed to test the device across a diverse patient population, with over 80% admitted hospital inpatients monitored in a controlled environment.
Baseline metrics
| Metric | Baseline average |
|---|---|
| Systolic BP (SBP) | 122.78 ± 20.35 mmHg |
| Diastolic BP (DBP) | 79.35 ± 12.11 mmHg |
| Pulse Rate (PR) | 80.36 ± 13.18 bpm |
| Oxygen Saturation (SpO₂) | 97.23 ± 1.59% |
Methodology
Phase 1 established baseline accuracy with 24 subjects using Mean Absolute Difference (MAD). Once MAD criteria were met, Phase 2 proceeded with the remaining 226 subjects.
Stable, resting conditions in a supine position against the clinical gold standard.
Inducing natural BP variation (supine to standing) to achieve a >4 mmHg change from calibration.
Testing at least 6 hours post-calibration to validate long-term stability and algorithm ageing.
Results
Bland-Altman plots assessed measurement validity and estimated bias with 95% confidence intervals.
| Metric | Estimated bias (95% CI) | Outside limit of agreement | Pearson correlation |
|---|---|---|---|
| Systolic BP (SBP) | -0.377 mmHg (-0.758 to 0.004) | 3.6% | 0.959 |
| Diastolic BP (DBP) | 0.773 mmHg (0.516 to 1.031) | 4.6% | 0.949 |
| Pulse Rate (PR) | -0.078 bpm (-0.253 to 0.098) | 5.4% | 0.982 |
| Oxygen Saturation (SpO₂) | -0.173% (-0.243 to -0.103) | 4.3% | 0.808 |
Conclusion
The trial confirms that the V-CHEK cuffless monitor provides daytime blood pressure, heart rate and SpO₂ measurements during resting conditions that are highly comparable to traditional sphygmomanometers.
The negligible biases and strong correlation coefficients validate its clinical utility as an accessible, non-invasive tool for continuous BP assessment and hypertension management.
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