None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. BP instruments currently in use by HCPs 2. Instruments submitted for assessment voluntarily by HCPs 3. Devices used in routine outpatient or inpatient care
Exclusion criteria
Exclusion criteria: 1. Non-functional devices beyond repair 2. Instruments not used in clinical settings 3. Devices without identifiable manufacturer/branding (if essential details are missing)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean difference (bias) between test device readings and a certified reference standard for systolic and diastolic BP (mmHg) measured at a single assessment. 2. Proportion of BP measuring devices that meet predefined accuracy criteria (e.g., mean bias within 5 mmHg) compared with the reference standard. 3. Proportion of BP devices found to be physically intact and functionally operational based on a standardized inspection checklist at the time of assessment. 4. Inter-instrument variation in BP readings (mean absolute difference in mmHg) between mercury, aneroid, and digital devices assessed using paired measurements.Timepoint: At the time of device evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the association between device accuracy and actors such as device type, brand, age, frequency of use, and history of calibration. 2. To determine the proportion of devices with valid calibration. 3. To measure the change in device accuracy in relation to device age and usage frequency. 4. To compare device performance across different healthcare settings including primary and secondary care and rural and urban locations. 5. To compare the accuracy performance of devices across different brands and models. 6. To generate recommendations for standard procedures for calibration and validation of blood pressure devices. 7. To assess operational feasibility including time required for device evaluation and participation rate of healthcare sites.Timepoint: At the time of device evaluation. | — |
Countries
India
Contacts
Dr. Bharats Clinic