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Validation of automatic office BP instrument

Clinical validation of the Sensio automatic office BP instrument Sensio-AOBP1

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/01/030429
Enrollment
100
Registered
2021-01-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: I10- Essential (primary) hypertension

Interventions

Sponsors

Sensio Enterprises Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult subjects (aged between 21 and 65 years old) Either healthy or hypertensive individuals Subjects that have signed the informed consent form

Exclusion criteria

Exclusion criteria: Subjects for whom oscillometric and assisted oscillometric measurement of BP may be difficult due to physical handicap, pain, or device reporting error Subject or volunteer who refuse to enter the study Patients who are currently in hospitalization or in medical assessment Subjects with ventricular tachycardia (heart rate at rest > 120bpm) Subjects with atrial fibrillation Subjects with anxiety Subjects with arm paralysis Women in known pregnancy Subjects with the upper arm circumference > 64 cm Subjects with central phalanx of middle finger circumference > 71 mm or Subjects with the exfoliative skin diseases (limitation due to participant discomfort) Subjects with lymphoedema (limitation due to participant discomfort)

Design outcomes

Primary

MeasureTime frame
The primary outcome is assessed in terms of the probability of an error within 10mmHg mean and 5 mmHg standard deviation.Timepoint: NA

Secondary

MeasureTime frame
NoneTimepoint: None

Countries

India

Contacts

Public ContactDr Venkatesh Vadde

Mazumdar Shaw Medical Center

madhavi.kv.dr@narayanahealth.org8147271619

Outcome results

None listed

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