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

Not Applicable

Completed

• Conditions: Blood Pressure
• Interventions: Device: BPro

• Registration Number: NCT03997461
• Lead Sponsor: Pontificia Universidad Catolica de Chile

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2018-09-26
• Study First Submitted: 2019-06-20
• Study First Submitted QC: 2019-06-23
• Study First Posted: 2019-06-25
• Primary Completion: 2019-07-30
• Study Completion: 2019-07-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-18
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Able to give informed consent

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BPro vs Oscar 2	BPro	Blood pressure measurement with BPro and Oscar 2 simultaneously during 24 hours under ambulatory conditions

Primary Outcome Measures

Name	Time	Method
Difference in systolic blood pressure taken simultaneously by BPro and Oscar 2 devices	24 hours	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
Difference in diastolic blood pressure taken simultaneously by BPro and Oscar 2 devices	24 hours	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

Trial Locations

Locations (1)

Institute for Biological and Medical Engineering; 🇨🇱 Santiago, Metropolitana, Chile