跳至主要内容
临床试验/CTRI/2025/12/099659
CTRI/2025/12/099659尚未招募不适用

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

Dr. Bharat Bhushan Kukreja1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年2月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1

研究概览

简要总结

Blood pressure (BP) measurement is a fundamental clinical procedure for the diagnosis and management of hypertension. Accurate BP readings are essential not only for individual patient care but also for population-level health management and policy decisions (Pickering et al., 2005; Parati et al., 2014). However, the reliability of these measurements depends heavily on the accuracy, maintenance, and calibration of the instruments used (O’Brien et al., 2013). In India, a wide variety of BP measuring devices are in clinical use. These include mercury sphygmomanometers, aneroid devices, and different types of automated digital monitors (Gupta et al., 2019). These instruments are employed by healthcare professionals (HCPs) across all levels of care— primary, secondary, and tertiary. However, very little is known about their current accuracy, condition, or calibration status (Sharman et al., 2020). Most BP instruments used in outpatient clinics and hospitals are never routinely calibrated after purchase (Veiga et al., 2019). Moreover, many HCPs are unaware of the need for periodic validation, and no standard national guidelines currently exist to ensure the quality control of these devices (Gupta & Xavier, 2018). While mercury sphygmomanometers have long been considered the gold standard, they pose occupational and environmental hazards and are being phased out globally (Myers et al., 2010; WHO, 2011). Aneroid devices are more portable and widely used, but they are prone to mechanical wear and drift over time (Jones et al., 2001). Digital BP monitors are now being used increasingly, particularly in primary care settings, but their accuracy varies significantly by brand, model, and maintenance conditions (Stergiou et al., 2018; Sharman et al., 2020).

研究设计

研究类型
Observational

入排标准

年龄范围
3.00 Month(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • BP instruments currently in use by HCPs
  • Instruments submitted for assessment voluntarily by HCPs
  • Devices used in routine outpatient or inpatient care.

排除标准

  • Non-functional devices beyond repair
  • Instruments not used in clinical settings
  • Devices without identifiable manufacturer/branding (if essential details are missing).

研究者

发起方
Dr. Bharat Bhushan Kukreja
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Bharat Bhushan Kukreja

Dr. Bharats Clinic

研究点 (1)

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