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

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Hypertension
• Interventions: Diagnostic Test: Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement

• Registration Number: NCT03732924
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-11-05
• Study First Submitted QC: 2018-11-05
• Study First Posted: 2018-11-07
• Study Start: 2018-11-15
• Primary Completion: 2020-02-15
• Study Completion: 2020-07-15
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-06
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 618

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Five minute rest	Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement	-
Zero minute rest	Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement	-

Primary Outcome Measures

Name	Time	Method
Difference in systolic and diastolic BP in patients randomized to zero or five minutes wait before the AOBP measurement.	4 months - 1 yr	difference in blood pressure

Secondary Outcome Measures

Name	Time	Method
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.	4 months - 1yr	difference in blood pressure

Trial Locations

Locations (1)

Sunnybrook & Women's College Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada