Blood Pressure, Cardiovascular Diseases, Cardiovascular Risk Factor, Hypertension
Conditions
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.
Interventions
OTHEROrder 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.
Sponsors
Vital Strategies
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in systolic BP in appropriately-sized cuff vs. too small cuff | Up to 90 minutes | Difference between (1) 1st systolic BP and (2) average of 3 systolic BP from measurements (mmHg). |
| Difference in systolic BP in appropriately-sized cuff vs. too large cuff | Up to 90 minutes | Difference between (1) 1st systolic BP and (2) average of 3 systolic BP from measurements (mmHg). |
| Difference in diastolic BP in appropriately-sized cuff vs. too small cuff | Up to 90 minutes | Difference between (1) 1st diastolic BP and (2) average of 3 diastolic BP from measurements (mmHg). |
| Difference in diastolic BP in appropriately-sized cuff vs. too large cuff | Up to 90 minutes | Difference between (1) 1st diastolic BP and (2) average of 3 diastolic BP from measurements (mmHg). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in blood pressure based on arm circumference | Up to 90 minutes | To determine the blood pressure difference based on arm circumference (continuous). |
| Difference in blood pressure based on BMI | Up to 90 minutes | To determine the blood pressure difference based on normal BMI (\<25 kg/m2) vs. overweight BMI (25 kg/m2-29.99 kg/m2) vs. Class I Obesity (30 kg/m2-34.99 kg/m2) vs. ≥Class II Obesity (\>35 kg/m2). |
| Difference in blood pressure based on hypertension status | Up to 90 minutes | To determine the blood pressure difference based on hypertensive (≥140/90 based on triplicate measures using appropriately sized cuff) vs. non-hypertensive participants. |
Countries
United States
Outcome results
None listed