Development and testing of a new Blood Pressure monitor Using pulse sounds and Signals

Not yet recruiting

• Conditions: Adults and children aged 3 years and above visiting the OPD; Other problems related to medicalfacilities and other health care, (2) ICD-10 Condition: I489||Unspecified atrial fibrillation and atrial flutter, (3) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, (4) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, (5) ICD-10 Condition: E669||Obesity, unspecified,

• Registration Number: CTRI/2025/06/088554
• Lead Sponsor: Mr Siddharth Dhawan

Brief Summary

Hypertension is a majornon-communicable disease contributing significantly to global morbidity andmortality. Accurate blood pressure (BP) measurement is essential for diagnosis,treatment, and prevention of complications. Traditional mercury sphygmomanometersusing Korotkoff sounds, though considered the gold standard, require trainedpersonnel, are time-consuming, and pose environmental risks. Automatedoscillometric devices are now widely used due to their ease of operation butmay show significant inaccuracies (up to plus or minus 15 mmHg). Therefore,there is a need for more accurate devices.

The objective of thisstudy is to clinically develop and validate a novel BP device (Walnut Pvt Ltd)integrating both Korotkoff sounds and oscillometric waveforms to enhanceaccuracy.

The study will be amulticenter experimental trial involving 1020 participants in the developmentphase and 600 participants in the validation phase, including general andspecial populations (pregnant women, atrial fibrillation, mid-arm circumferencemore than 42 cm).

Participants willundergo BP measurement with both the novel device and the standard referencedevice as per AAMI/ESH/ISO protocols. Validation will involve sequential BPmeasurements, stringent inclusion/exclusion criteria, and supervisedassessments. Acceptable performance will be defined as less than or equal to 5mmHg mean difference in at least 85% of cases. Data will be analyzed usingSPSS, and results presented via mean differences, standard deviations, andBland-Altman plots. Special population data, such as those with pre-eclampsia,will be separately analyzed.

The study aims to support the development of a user-friendly, accurate,non-invasive BP measuring device suitable for adults and children acrossdiverse populations.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-07
• Last Update Posted: 2025-10-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 1620

Inclusion Criteria

• Willingness to provide informed consent and voluntary participation in the study 2.
• Both normotensive or hypertensive Participants either on treatment or not on treatment for hypertension 3.
• Special population: pregnancy including pre-eclampsia, midarm circumference of greater than 42 cm and atrial fibrillation.

Exclusion Criteria

• 1.K1 or K5 of Korotkoff sounds is not audible 2.
• Participants with systolic BP difference more than 12 mmHg and/or diastolic BP difference more than 8 mmHg in any 2 of the 4 reference (average of two observers) BP measurements (R1 to R4) 3.
• BP measurement beyond the desired target reading of the measuring apparatus 4.
• Midarm circumference and cuff size beyond the desired target 5.
• Target population beyond the desired special groups.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation phase:	one time
Development phase:	one time
iii. Low accuracy: The estimated error (difference between the reference and test device measurement)of more than 10 mmHg is found in at least 85% cases	one time
1. Display of BP reading by index device through the integration of Korotkoff sounds and oscillatory waveform	one time
1. Frequency of tolerable error of less than or equal to 5 mmHg	one time
2. Whether estimated tolerable error (less than or equal to 5 mmHg) is found in at least 85% cases	one time
3. Level of accuracy	one time
i. High accuracy: The estimated error (difference between the reference and test device measurement) of less than or equal to 5 mmHg is found in at least 85% cases	one time
ii. Moderate accuracy: The estimated error (difference between the reference and test device measurement)of more than 5 mmHg but less than or equal to 10 mmHg is found in at least 85% cases	one time

Secondary Outcome Measures

Name	Time	Method
Development phase:	1. Any adverse event associated with the use of the device in the participants

Trial Locations

Locations (3)

All India Institute of Medical Sciences, Nagpur; 🇮🇳 Nagpur, MAHARASHTRA, India

Chettinad Hospital and Research Institute; 🇮🇳 Kancheepuram, TAMIL NADU, India

Rajendra Institute of Medical Sciences; 🇮🇳 Ranchi, JHARKHAND, India

All India Institute of Medical Sciences, Nagpur

🇮🇳Nagpur, MAHARASHTRA, India

Dr Udit Narang

Principal investigator

9930805548

uditnarang@aiimsnagpur.edu.in