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

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

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

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Device: BPro

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Metropolitana
    • Santiago, Metropolitana, Chile, 7820436
      • Institute for Biological and Medical Engineering

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to give informed consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BPro vs Oscar 2; Blood pressure measurement with BPro and Oscar 2 simultaneously during 24 hours under ambulatory conditions	Device: BPro; BPro and Oscar 2 comparison for 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Pontificia Universidad Catolica de Chile
• Collaborators: Comisión Nacional de Investigación Científica y Tecnológica
• Investigators: Principal Investigator: Maria Rodriguez Fernandez, PhD, Pontificia Universidad Catolica de Chile

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2018
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): July 30, 2019

Study Registration Dates

• First Submitted: June 20, 2019
• First Submitted That Met QC Criteria: June 23, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Blood Pressure
• Other Study ID Numbers: 170706006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No