NCT04610775

Cuff(SZ): The Cuff Size Blood Pressure Measurement Trial

The Cuff Size Blood Pressure Measurement Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

To determine the impact of overcuffing (using a too-large cuff) and undercuffing (using a too-small cuff) on initial BP and average BP measurements when using an automated BP device, overall and stratified by appropriate cuff size To determine if the impact over- or under-cuffing differs based on the following patient characteristics: 1. Hypertensive (≥140/90 based on triplicate measures using appropriately sized cuff) vs. non-hypertensive. 2. Arm circumference (continuous) 3. Obesity status

Detailed description

The investigators propose a cross-sectional study of adult participants recruited from the community. Enrolled participants will have 2-3 sets of three automated BPs measured, each set with a different cuff size. To accomplish this, the investigators will utilize a 2-3 period cross-over design: • Two or three different periods with 3 automated BP measurements, using a BP cuff that is: * Appropriately sized based on mid-upper arm circumference ( standard) * Too small (one size lower than appropriate) * Too large (one size higher than appropriate) Individuals in whom the smallest available cuff (small adult) and largest available cuff (extra-large cuff) is appropriate for their arm circumference will only be able to undergo two periods of BP measurements.

Conditions

• Hypertension
• Blood Pressure
• Cardiovascular Diseases
• Cardiovascular Risk Factor

Interventions

Type	Name	Description
OTHER	Order of cuff sizes during blood pressure measurements	Each participant will have 4 sets of 3 blood pressure measurements taken. The participants will be randomized to the order in which the cuff sizes are used.

Timeline

• Start date: 2021-03-16
• Primary completion: 2021-10-25
• Completion: 2021-10-25
• First posted: 2020-11-02
• Last updated: 2021-12-13

Locations

1 site across 1 country: United States