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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Blood Pressure

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