VALIDATION OF AUTOMATIC DEVICES IN THE CLINIC: VALIDAC-1

Not Applicable

• Conditions: Arterial hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases

• Registration Number: RPCEC00000400
• Lead Sponsor: Institute of Cardiology and Cardiovascular Surgery (ICCCV)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-04
• Study Completion: 2023-03-15
• Results First Posted: 2023-10-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 85

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.<br>

Secondary Outcome Measures

Name	Time	Method
ot applicable