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NCT03732924 Clinical Trial

Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement

Hypertension Clinical Trial

Official title:
Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement: the Impact of a 5 Minute Rest Time on AOBP Measurement

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03732924
Other study ID # 181-2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2018
Est. completion date July 15, 2020

Study information
Verified date September 2020
Source Sunnybrook Health Sciences Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Hypertension Canada Clinical Practice Guidelines for blood pressure measurement using AOBP recommend against any wait time prior to commencing the measurement. The recent AHA guidelines however call for a 5-minute rest first. In uncontrolled hypertension, AOBP is typically higher than the daytime readings from ambulatory blood pressure monitoring (ABPM), but this is not the case for patients with controlled hypertension.

Description:

Objective:

Does a 5 minute rest or no rest before measurement using AOBP provide the most accurate reading in patients with controlled and uncontrolled hypertension, and in patients with white coat hypertension compared to daytime ABPM?

Implications:

Through this study, we hope to:

(i) Advance the understanding of the role of AOBP in measuring blood pressure. (ii) Determine whether a 5-minute rest, or no rest at all is needed prior to AOBP measurement.

(iii) Assess the relationship of AOBP to daytime ABPM for patient with controlled and uncontrolled hypertension and in patients with white coat hypertension.

Recruitment information / eligibility
Status Completed
Enrollment 618
Est. completion date July 15, 2020
Est. primary completion date February 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 years or older

- Referred for ABPM

- Written informed consent

Exclusion Criteria:

- Unable to perform AOBP or ABPM for some reason

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement
To compare the difference between the daytime ABPM and AOBP with zero or five minutes wait time.

Locations
Country Name City State
Canada Sunnybrook & Women's College Health Sciences Centre Toronto Ontario

Sponsors (2)
Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre KMH Cardiology and Diagnostic Centres

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference in systolic and diastolic BP in patients randomized to zero or five minutes wait before the AOBP measurement. difference in blood pressure 4 months - 1 yr
Secondary Difference in systolic and diastolic BP between the AOBP and daytime ABPM in patients randomized to zero or five minutes wait before the AOBP measurement. difference in blood pressure 4 months - 1yr
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