Cuff(SZ): The Cuff Size Blood Pressure Measurement Trial
Status
Completed
Conditions
Hypertension
Cardiovascular Diseases
Cardiovascular Risk Factor
Blood Pressure
Treatments
Other: Order of cuff sizes during blood pressure measurements
Details and patient eligibility
About
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:
- Hypertensive (≥140/90 based on triplicate measures using appropriately sized cuff) vs. non-hypertensive.
- Arm circumference (continuous)
- Obesity status
Full 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.
Enrollment
194 patients
Sex
All
Ages
18 to 80 years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Screening
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
None (Open label)
194 participants in 24 patient groups
Small Cuff (0, +1, +2, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Small, Regular, Large, Small
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Small Cuff (0, +2, +1, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Small, Large, Regular, Small
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Small Cuff ( +1, 0, +2, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Small, Large, Small
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Small Cuff ( +1, +2, 0, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Small, Small
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Small Cuff ( +2, 0, +1, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Small, Regular, Small
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Small Cuff ( +2, +1, 0, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Small, Small
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Regular Cuff (0, -1, +1, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Small, Large, Regular
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Regular Cuff (0, +1, -1, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Small, Regular
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Regular Cuff (-1, 0, +1, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Small, Regular, Large, Regular
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Regular Cuff (-1, +1, 0, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Small, Large, Regular, Regular
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Regular Cuff (+1, -1, 0, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Small, Regular, Regular
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Regular Cuff (+1, 0, -1, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Small, Regular
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Large Cuff (-1, 0, +1, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Extra Large, Large
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Large Cuff (-1, +1, 0, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Extra Large, Large, Large
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Large Cuff (0, +1, -1, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Extra Large, Regular, Large
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Large Cuff (0, -1, +1, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Extra Large, Large
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Large Cuff (+1, 0, -1, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Large, Regular, Large
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Large Cuff (+1, -1, 0, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Regular, Large, Large
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Extra Large Cuff (0, -2, -1, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Regular, Large, Extra Large
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Extra Large Cuff (0, -1, -2, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Large, Regular, Extra Large
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Extra Large Cuff (-1, 0, -2, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Extra Large, Regular, Extra Large
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Extra Large Cuff (-1, -2, 0, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Extra Large, Extra Large
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Extra Large Cuff (-2, -1, 0, 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Extra Large, Extra Large
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Extra Large Cuff (-2, 0, -1 0)
Other group
Description:
The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Extra Large, Large, Extra Large
Treatment:
Other: Order of cuff sizes during blood pressure measurements
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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