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VALIDATION OF AUTOMATIC DEVICES IN THE CLINIC: VALIDAC-1

Validation study for the clinical use of the Hipermax BF automatic blood pressure measurement device in the general population. - VALIDAC HIPERMAX-BF

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
RPCEC
Registry ID
RPCEC00000400
Enrollment
85
Registered
2022-02-04
Start date
2022-03-03
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Arterial hypertension

Interventions

Participants enrolled in the study will have their blood pressure measured eigth times with both the auscultatory method as the gold standard for the reference measurement and the oscillometer with th
Sphygmomanometers

Sponsors

Institute of Cardiology and Cardiovascular Surgery (ICCCV)
Lead Sponsor
Ministry of Public Health (MINSAP)
Collaborator
COMBIOMED Digital Medical Technology
Collaborator

Eligibility

Sex/Gender
All
Age
12 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. In all cases, informed consent will be obtained. 2. Age 12 years or older, not pregnant 3. No arrhythmias (Electrocardiogram) 4. Blood pressure in the SBP 80-220 mmHg and DBP 50-120 mmHg ranges (Initial blood pressure measurement)

Exclusion criteria

Exclusion criteria: 1. Refusal to be part of the study. 2. Belonging to a group classified as a special population: children under 12 years of age or pregnant women. 3. K5 Korotkoff sound not audible in one subject. 4. Cardiac arrhythmias

Design outcomes

Primary

MeasureTime frame
Blood pressure value measured with the HIPERMAX BF (equipment under test) and the Mercury Column (reference equipment). Measurement time: A maximum of eight pairs of readings will be taken per subject, with intervals of 1 min. The evaluation criteria will be the relationship between the measurement of the HIPERMAX BF with that carried out by two certified experts using the reference device.

Countries

Cuba

Contacts

Public ContactYamile Valdes Gonzalez

University Hospital "General Calixto Garcia"

yamile.valdes@infomed.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026