V-CHEK Clinical Trial
Comprehensive Evaluation of Cuffless Blood Pressure Monitoring
A large-scale Indian clinical study validating V-CHEK against mercury sphygmomanometer — 250 patients at Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bengaluru.
Blood pressure monitoring is undergoing a paradigm shift from traditional cuff-based methods to cuffless wearable technology.
In the era of advanced digital health technology, the approach to blood pressure (BP) monitoring is shifting from in-office and home BP monitoring toward cuffless and wearable technology. Traditional cuff-based methods — introduced by Scipione Riva-Rocci almost 125 years ago — can be cumbersome, inconvenient, and potentially inaccurate, especially for frequent measurements.
Advancements in sensor technology, signal processing, and machine learning have opened opportunities for cuffless methods that establish precise relationships between biomedical signals like photoplethysmography (PPG) and changes in BP.
Background
Conventional BP devices using inflatable cuffs offer limited snapshots. Cuffless technologies enable continuous monitoring, potentially revolutionizing hypertension management.
Objective
Compare accuracy of V-CHEK cuffless BP monitor against mercury sphygmomanometer and pulse oximeter for BP, heart rate, and SpO₂ in resting conditions.
Study Design
Cross-sectional study with 250 patients. Statistical analysis included Bland-Altman agreement assessment with 95% confidence intervals.
Strong agreement across all vital parameters measured
−0.38
SBP Bias (mmHg)
95% CI: −0.76 to 0.004
0.77
DBP Bias (mmHg)
95% CI: 0.52 to 1.03
−0.08
Heart Rate Bias (bpm)
95% CI: −0.25 to 0.09
0.96
SBP Agreement
Pearson correlation coefficient
| Metric | Result |
|---|---|
| SBP Bias | −0.38 mmHg (95% CI: −0.76 to 0.004) — 3.6% outside limits |
| DBP Bias | 0.77 mmHg (95% CI: 0.52 to 1.03) — 4.6% outside limits |
| Pulse Rate Bias | −0.08 bpm (95% CI: −0.25 to 0.09) — 5.4% outside limits |
| SpO₂ Bias | −0.17% (95% CI: −0.24 to −0.10) — 4.3% outside limits |
| SBP Correlation | 0.959 (95% CI: 0.953–0.965) |
| DBP Correlation | 0.949 (95% CI: 0.941–0.955) |
| PR Correlation | 0.982 (95% CI: 0.979–0.985) |
| SpO₂ Correlation | 0.808 (95% CI: 0.782–0.832) |
Non-invasive, cuffless BP monitor measuring BP, heart rate, and oxygen saturation
- Optical sensors embedded in integrated hardware capture physiological signals at the fingertip
- Waveforms analyzed by V-CHEK algorithms determine SBP and DBP relative to calibration point
- Measured data displayed on device and smartphone app via Bluetooth
- Requires no patient interaction — comfortable for daily home BP measurements
- Calibration using sphygmomanometer reference before first use
250 patients with cardiovascular diseases in Bangalore, India
| Total Participants | 250 patients |
|---|---|
| Male / Female | 56.4% / 43.6% |
| Average Age | 51.6 ± 13.1 years |
| Inpatients | >80% of subjects |
| With Hypertension | 154 patients |
| With Diabetes | 105 patients |
| Family History of HT | 66.9% |
Inclusion Criteria:
- Patients with hypertension
- Patients with cardiovascular disease including atrial fibrillation
- Healthy employees of the institution
- Patients with comorbidities
- Geriatric patients
Exclusion Criteria:
- Pregnant women
- Severe cardiovascular or respiratory diseases
- Recent MI, stroke, or unstable angina
- Patients below 18 years
Step 1: Rest
Patient rested 5 min seated, hand open and relaxed, legs uncrossed.
Step 2: Reference BP
Three reference measurements (Ref1, Ref2, Ref3) using mercury sphygmomanometer. Average SBP and DBP entered in app.
Step 3: V-CHEK Measurement
Within 60s of reference, place finger on sensor. All four vital signs displayed in 40–60 seconds.
- V-CHEK provides daytime BP measurements comparable to traditional sphygmomanometer
- Negligible bias for BP (−0.377 mmHg), heart rate (−0.078 bpm), and SpO₂ (0.173%)
- No statistically significant differences in resting SBP and DBP
- Easy to learn and use across all age groups without assistance
- Promising tool for cuffless BP monitoring in clinical and home settings
Published in: Journal of Indian College of Cardiology, Volume 14, Issue 3, July–September 2024
Authors: Rahul S. Patil, C. N. Manjunath, K. R. Nishanth
Institution: Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bengaluru
DOI: 10.4103/jicc.jicc_46_23