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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Hypertension
• Intervention / Treatment: Diagnostic test: Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement

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 Type: Interventional
• Enrollment (Actual): 618
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook & Women's College Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Five minute rest	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.
ACTIVE_COMPARATOR: Zero minute rest	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: KMH Cardiology and Diagnostic Centres
• Investigators: Principal Investigator: Sheldon W Tobe, MD, Sunnybrook Research Institute

Publications and helpful links

General Publications

• Tobe SW, Dubrofsky L, Nasser DI, Rajasingham R, Myers MG. Randomized Controlled Trial Comparing Automated Office Blood Pressure Readings After Zero or Five Minutes of Rest. Hypertension. 2021 Aug;78(2):353-359. doi: 10.1161/HYPERTENSIONAHA.121.17319. Epub 2021 Jun 28.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2018
• Primary Completion (ACTUAL): February 15, 2020
• Study Completion (ACTUAL): July 15, 2020

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 5, 2018
• First Posted (ACTUAL): November 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 6, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 181-2018

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