Cuff(SZ): The Cuff Size Blood Pressure Measurement Trial
- Conditions
- HypertensionBlood PressureCardiovascular DiseasesCardiovascular Risk Factor
- Interventions
- Other: Order of cuff sizes during blood pressure measurements
- Registration Number
- NCT04610775
- Lead Sponsor
- Johns Hopkins University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 194
- 18-80
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Small Cuff (0, +2, +1, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Small, Large, Regular, Small Small Cuff ( +2, 0, +1, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Small, Regular, Small Regular Cuff (0, +1, -1, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Small, Regular Regular Cuff (-1, +1, 0, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Small, Large, Regular, Regular Regular Cuff (+1, -1, 0, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Small, Regular, Regular Large Cuff (-1, 0, +1, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Extra Large, Large Large Cuff (-1, +1, 0, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Extra Large, Large, Large Large Cuff (+1, 0, -1, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Large, Regular, Large Small Cuff (0, +1, +2, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Small, Regular, Large, Small Small Cuff ( +1, 0, +2, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Small, Large, Small Small Cuff ( +1, +2, 0, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Small, Small Regular Cuff (0, -1, +1, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Small, Large, Regular Regular Cuff (-1, 0, +1, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Small, Regular, Large, Regular Large Cuff (0, +1, -1, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Extra Large, Regular, Large Extra Large Cuff (-1, -2, 0, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Extra Large, Extra Large Extra Large Cuff (-2, -1, 0, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Extra Large, Extra Large Small Cuff ( +2, +1, 0, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Small, Small Large Cuff (0, -1, +1, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Extra Large, Large Large Cuff (+1, -1, 0, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Regular, Large, Large Regular Cuff (+1, 0, -1, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Small, Regular Extra Large Cuff (0, -2, -1, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Regular, Large, Extra Large Extra Large Cuff (0, -1, -2, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Large, Regular, Extra Large Extra Large Cuff (-1, 0, -2, 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Extra Large, Regular, Extra Large Extra Large Cuff (-2, 0, -1 0) Order of cuff sizes during blood pressure measurements The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Extra Large, Large, Extra Large
- Primary Outcome Measures
Name Time Method 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 large 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 small cuff Up to 90 minutes Difference between (1) 1st diastolic BP and (2) average of 3 diastolic BP from measurements (mmHg).
- Secondary Outcome Measures
Name Time Method 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.
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).
Trial Locations
- Locations (1)
Johns Hopkins ProHealth Research Center
🇺🇸Baltimore, Maryland, United States