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Clinical Accuracy Investigation for Patient Monitor Blood Pressure

Clinical Accuracy Investigation for Patient Monitor Blood Pressure

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500100901
Enrollment
Unknown
Registered
2025-04-16
Start date
2025-04-21
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

hypertension

Interventions

Gold Standard:The mercury sphygmomanometer was adopted as the gold standard for comparison.
Index test:the average difference of NIBP (SYS/DIA) is <= +- 5.0mmHg (+- 0.67kPa) the standard deviation of NIBP (SYS/DIA) is <= 8.0mmHg (1.07kPa)

Sponsors

Gaozhou People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1Voluntarily participate and sign an informed consent form; 2Age range: 3-80 years old, regardless of gender; 3Patients or healthy volunteers who require blood pressure testing; 4Those who meet the limb range distribution requirements of this clinical trial.

Exclusion criteria

Exclusion criteria: 1Relevant data cannot be traced back; 2Individuals with very faint Korotkoff sounds, making accurate judgment impossible; 3Patients with arteritis or arterial occlusive disease; 4Individuals whose limb range exceeds the prescribed range of the cuff; 5Pregnant subjects (including patients with preeclampsia); 6Participated in clinical trials of other drugs within 30 days; 7Researchers believe that participants who are not suitable for this clinical study should not participate in the trial.

Design outcomes

Primary

MeasureTime frame
systolic pressure;diastolic pressure;Accuracy;Sensitivity;Specificity;

Countries

China

Contacts

Public ContactYong Cao

Gaozhou People's Hospital

276673546@qq.com+86 668 666 6592

Outcome results

None listed

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