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Evaluation, Calibration and Certification of Blood Pressure Measuring Devices used by Healthcare Providers: A Pan-India Cross-Sectional Observational Study

A Cross-Sectional Evaluation of Accuracy, Calibration Status and Certification Compliance of Blood Pressure Measuring Devices used by healthcare Providers Across India

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/12/099659
Enrollment
100
Registered
2025-12-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Nil: Nil

Sponsors

Dr. Bharat Bhushan Kukreja
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactDr Bharat Bhushan Kukreja

Dr. Bharats Clinic

bharatkukreja@hotmail.com9864093048

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026