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

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ClinicalTrials.gov Identifier: NCT03997461
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
Comisión Nacional de Investigación Científica y Tecnológica
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Blood Pressure Device: BPro Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Arterial Tonometry Sensor (BPro) With Standard Oscillometric Blood Pressure Monitoring Device (Oscar 2) for Ambulatory Use
Actual Study Start Date : September 26, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : July 30, 2019

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




Primary Outcome Measures :
  1. Difference in systolic blood pressure taken simultaneously by BPro and Oscar 2 devices [ Time Frame: 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

  2. Difference in diastolic blood pressure taken simultaneously by BPro and Oscar 2 devices [ Time Frame: 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



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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able to give informed consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997461


Contacts
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Contact: Maria Rodriguez Fernandez, PhD +56 2 2354 1106 marodriguezf@uc.cl

Locations
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Chile
Institute for Biological and Medical Engineering Recruiting
Santiago, Metropolitana, Chile, 7820436
Contact: Maria Rodriguez Fernandez, PhD    +56 2 2354 1106    marodriguezf@uc.cl   
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Comisión Nacional de Investigación Científica y Tecnológica
Investigators
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Principal Investigator: Maria Rodriguez Fernandez, PhD Pontificia Universidad Catolica de Chile

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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT03997461     History of Changes
Other Study ID Numbers: 170706006
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Pontificia Universidad Catolica de Chile:
Blood Pressure