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International Protocol Based Clinical Evaluation of Non-invasive Automated Sphygmomanometers

International Protocol Based Clinical Evaluation of Non-invasive Automated Sphygmomanometers

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500110165
Enrollment
Unknown
Registered
2025-10-09
Start date
2025-10-13
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Hypertension

Interventions

Index test:non-invasive automatic blood pressure device

Sponsors

First Affiliated Hospital of Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Participants of either gender, aged over 18 years old, with either normal or abnormal blood pressure, are eligible, which complies with the ISO 81060-2 standard requirements

Exclusion criteria

Exclusion criteria: 1. Patients with skin diseases, infections, or trauma around the measurement site; 2. Patients with arrhythmia (irregular heartbeat); 3. Patients using extracorporeal circulation devices; 4. Patients with poor peripheral circulation, bilateral upper extremity arteriovenous thrombosis, or other conditions that affect blood pressure measurement results; 5. Patients with coagulation disorders or artificial blood vessels; 6. Patients whose arm circumference exceeds the range of the cuff; 7. Patients whose blood pressure distribution range exceeds the standard requirements; 8. Patients with severe physical or mental diseases, unconsciousness, or inability to move freely, or other conditions.

Design outcomes

Primary

MeasureTime frame
blood pressure;measurement accuracy (mean with standard deviation);

Countries

China

Contacts

Public ContactYi Wan

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