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CTRI Number  CTRI/2025/12/099659 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On: 20/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluation, Calibration and Certification of Blood Pressure Measuring Devices used by Healthcare Providers: A Pan-India Cross-Sectional Observational Study 
Scientific Title of Study   A Cross-Sectional Evaluation of Accuracy, Calibration Status and Certification Compliance of Blood Pressure Measuring Devices used by healthcare Providers Across India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bharat Bhushan Kukreja 
Designation  Principal Investigator 
Affiliation  Dr. Bharats Clinic 
Address  Room no.1, Ground floor,69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, Kamrup, Assam, 781001, India

Kamrup
ASSAM
781001
India 
Phone  9864093048  
Fax    
Email  bharatkukreja@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bharat Bhushan Kukreja 
Designation  Principal Investigator 
Affiliation  Dr. Bharats Clinic 
Address  Room no.1, Ground floor,69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, Kamrup, Assam, 781001, India

Kamrup
ASSAM
781001
India 
Phone  9864093048  
Fax    
Email  bharatkukreja@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bharat Bhushan Kukreja 
Designation  Principal Investigator 
Affiliation  Dr. Bharats Clinic 
Address  Room no.1, Ground floor,69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, Kamrup, Assam, 781001, India

Kamrup
ASSAM
781001
India 
Phone  9864093048  
Fax    
Email  bharatkukreja@hotmail.com  
 
Source of Monetary or Material Support  
Dr. Bharat Bhushan Kukreja Dr. Bharats Clinic Room no.1, Ground Floor, 69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, 781001 (Assam) Kamrup Assam 781001 India  
 
Primary Sponsor  
Name  Dr. Bharat Bhushan Kukreja 
Address  Room no.1, Ground floor,69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, Kamrup ASSAM 781001 India  
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bharat Bhushan Kukreja  Dr Bharats Clinic  Room no.1, Ground floor,69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, 781001(Assam) Kamrup ASSAM 781001 India
Kamrup
ASSAM 		 09864093048

bharatkukreja@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ECRC HOSPITAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  3.00 Month(s)
Age To  25.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  1. Non-functional devices beyond repair
2. Instruments not used in clinical settings
3. Devices without identifiable manufacturer/branding (if essential details are missing)  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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. 		 At the time of device evaluation. 
 
Secondary Outcome  
Outcome  TimePoints 
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. 		 At the time of device evaluation. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [bharatkukreja@hotmail.com].

  6. For how long will this data be available start date provided 01-02-2026 and end date provided 29-02-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   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).  
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