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Clinical investigation on accuracy of non-invasive automated sphygmomanometers

Validation of non-invasive automated sphygmomanometers according to the AAMI/ESH/ISO Universal Standard

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300067663
Enrollment
Unknown
Registered
2023-01-17
Start date
2023-01-17
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Hypertension

Interventions

Gold Standard:Noninvasive upper arm mercury sphygmomanometer
Index test:The AAMI/ESH/ISO Universal Standard

Sponsors

First Affiliated Hospital of Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: According to the standard requirements, no less than 85 patients, male or female, were included from the hospital patients, their family members or medical staff volunteers over the age of 12.

Exclusion criteria

Exclusion criteria: 1. Participants with skin diseases, infections, or wounds around the examination site; 2, arrhythmia; 3. Participants using extracorporeal circulation devices; 4. Participants with poor peripheral circulation and arteriovenous thrombosis of both upper limbs affecting blood pressure measurement; 5. Participants with coagulation dysfunction or artificial blood vessels; 6. Beyond the range of the cuff; 7. blood pressure distribution beyond the standard requirements; 8. Patients with severe physical or mental diseases, unconsciousness, inability to move freely, and other conditions.

Design outcomes

Primary

MeasureTime frame
Blood Pressure;—

Countries

China

Contacts

Public ContactYi Wan

First Affiliated Hospital of Air Force Medical University

wanyi@fmmu.edu.cn+86 29 8471 2676

Outcome results

None listed

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