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NCT03997461 Clinical Trial

Comparison of Arterial Tonometry Sensor With Standard Oscillometric Blood Pressure Monitoring Device

Blood Pressure Clinical Trial

Official title:
Comparison of Arterial Tonometry Sensor (BPro) With Standard Oscillometric Blood Pressure Monitoring Device (Oscar 2) for Ambulatory Use

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03997461
Other study ID # 170706006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 26, 2018
Est. completion date July 30, 2019

Study information
Verified date October 2019
Source Pontificia Universidad Catolica de Chile
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims at comparing the values of the blood pressure measurements obtained during 24 hours by an arterial tonometry device (BPRo) and a standard oscillometric blood pressure monitoring device (Oscar 2) under ambulatory conditions

Description:

The study aims at comparing the values of the blood pressure measurements obtained during 24 hours by an arterial tonometry device (BPRo) and a standard oscillometric blood pressure monitoring device (Oscar 2) under ambulatory conditions. Measurements will be taken at 15 minutes intervals during the day and 30 minutes intervals during the night.

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date July 30, 2019
Est. primary completion date July 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years and older
Eligibility Inclusion Criteria:

- Able to give informed consent

Exclusion Criteria:

- Difference in blood pressure between the arms higher than 10 mmHg

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• BPro
BPro and Oscar 2 comparison for 24 hours

Locations
Country Name City State
Chile Institute for Biological and Medical Engineering Santiago Metropolitana

Sponsors (2)
Lead Sponsor Collaborator
Pontificia Universidad Catolica de Chile Comisión Nacional de Investigación Científica y Tecnológica

Country where clinical trial is conducted

Chile, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference in systolic blood pressure taken simultaneously by BPro and Oscar 2 devices Mean of the absolute differences in systolic blood pressure (mmHg) taken simultaneously by BPro and Oscar 2 devices at 15 minutes intervals during the day and 30 minutes intervals during the night for a period of 24 hours 24 hours
Primary Difference in diastolic blood pressure taken simultaneously by BPro and Oscar 2 devices Mean of the absolute differences in diastolic blood pressure (mmHg) taken simultaneously by BPro and Oscar 2 devices at 15 minutes intervals during the day and 30 minutes intervals during the night for a period of 24 hours 24 hours
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