Clinical trial NCT04610775: Cuff(SZ): The Cuff Size Blood Pressure Measurement Trial
Official title: The Cuff Size Blood Pressure Measurement Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Blood Pressure
Cardiovascular Diseases
Cardiovascular Risk Factor
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Vital Strategies
First posted: 2020-11-02
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 18-80

Exclusion Criteria:

* Presence of the following on both arms: rashes, gauze dressings, casts, edema, paralysis, tubes, open sores or wounds, withered arms, A-V shunts, or if blood has been drawn from arm within last week.
* Being mentally impaired, pregnant.
* Arm circumference exceeding 50 cm.

Primary outcomes:
measure: Difference in systolic BP in appropriately-sized cuff vs. too small cuff
timeFrame: Up to 90 minutes
measure: Difference in systolic BP in appropriately-sized cuff vs. too large cuff
timeFrame: Up to 90 minutes
measure: Difference in diastolic BP in appropriately-sized cuff vs. too small cuff
timeFrame: Up to 90 minutes
measure: Difference in diastolic BP in appropriately-sized cuff vs. too large cuff
timeFrame: Up to 90 minutes
Secondary outcomes:
measure: Difference in blood pressure based on hypertension status
timeFrame: Up to 90 minutes
measure: Difference in blood pressure based on arm circumference
timeFrame: Up to 90 minutes
measure: Difference in blood pressure based on BMI
timeFrame: Up to 90 minutes
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins ProHealth Research Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Tammy Brady, MD,Phd
role: PRINCIPAL_INVESTIGATOR
References: