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

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Completed
CT.gov ID
NCT03732924
Collaborator
KMH Cardiology and Diagnostic Centres (Other)
618
1
2
20
30.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
618 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Diagnostic
Official Title:
Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement: the Impact of a 5 Minute Rest Time on AOBP Measurement
Actual Study Start Date :
Nov 15, 2018
Actual Primary Completion Date :
Feb 15, 2020
Actual Study Completion Date :
Jul 15, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age 18 years or older

  • Referred for ABPM

  • Written informed consent

Exclusion Criteria:
  • Unable to perform AOBP or ABPM for some reason

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sunnybrook & Women's College Health Sciences Centre Toronto Ontario Canada M4N 3M5

Sponsors and Collaborators

  • Sunnybrook Health Sciences Centre
  • KMH Cardiology and Diagnostic Centres

Investigators

  • Principal Investigator: Sheldon W Tobe, MD, Sunnybrook Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sheldon Tobe, Primary Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT03732924
Other Study ID Numbers:
  • 181-2018
First Posted:
Nov 7, 2018
Last Update Posted:
Sep 9, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 9, 2020