Testing the accuracy of a new blood pressure monitor
Validation of the CONTEC08C Oscillometric Blood Pressure Monitor in General Population According to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)
NA · Chinese Academy of Medical Sciences, Fuwai Hospital · NCT06457568
This study tests if a new blood pressure monitor works accurately for people aged 12 to 79.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 12 Years to 79 Years |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital (other) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06457568 on ClinicalTrials.gov |
What this trial studies
This study evaluates the accuracy of the CONTEC08C automated oscillometric upper-arm sphygmomanometer for measuring blood pressure in the general population. It aims to ensure that the device meets the standards set by the AAMI, ESH, and ISO for clinical use. Participants will have their blood pressure measured using this device to determine its reliability and effectiveness. The study includes individuals aged 12 to 79 years who consent to participate.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 12 to 79 years who are willing to participate and provide informed consent.
Not a fit: Patients with cardiac arrhythmias, pregnancy, or arm injuries incompatible with cuff use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved accuracy in blood pressure monitoring, enhancing patient care and management of hypertension.
How similar studies have performed: Other studies have shown success in validating blood pressure measurement devices, indicating that this approach is well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects aged 12 to 79 years * Subjects voluntarily participate in the clinical trial and sign the informed consent. Exclusion Criteria: * Subjects with cardiac arrhythmias; * Pregnancy; * Poor quality Korotkoff sounds; * Subject with an arm injury incompatible with the use of a cuff-based sphygmomanometer; * Other conditions that the investigator considers ineligible for clinical trial.
Where this trial is running
Beijing, Beijing Municipality
- Chinese Academy of Medical Sciences，Fuwai Hospital — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Ying Lou, MD — Chinese Academy of Medical Sciences, Fuwai Hospital
- Study coordinator: Ying Lou, MD
- Email: fuwailou1798@sina.com
- Phone: 86(10)88392170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Blood Pressure