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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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The Cuff Size Blood Pressure Measurement Trial

Conditions
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Hypertension, Blood Pressure, Cardiovascular Diseases, Cardiovascular Risk Factor

Intervention / Treatment
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* Other: Order of cuff sizes during blood pressure measurements


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Small Cuff (0, +1, +2, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Small, Regular, Large, Small | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Small Cuff (0, +2, +1, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Small, Large, Regular, Small | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Small Cuff ( +1, 0, +2, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Small, Large, Small | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Small Cuff ( +1, +2, 0, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Small, Small | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Small Cuff ( +2, 0, +1, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Small, Regular, Small | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Small Cuff ( +2, +1, 0, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Small, Small | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Regular Cuff (0, -1, +1, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Small, Large, Regular | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Regular Cuff (0, +1, -1, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Small, Regular | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Regular Cuff (-1, 0, +1, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Small, Regular, Large, Regular | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Regular Cuff (-1, +1, 0, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Small, Large, Regular, Regular | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Regular Cuff (+1, -1, 0, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Small, Regular, Regular | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Regular Cuff (+1, 0, -1, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Small, Regular | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Large Cuff (-1, 0, +1, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Extra Large, Large | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Large Cuff (-1, +1, 0, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Extra Large, Large, Large | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Large Cuff (0, +1, -1, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Extra Large, Regular, Large | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Large Cuff (0, -1, +1, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Extra Large, Large | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Large Cuff (+1, 0, -1, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Large, Regular, Large | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Large Cuff (+1, -1, 0, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Regular, Large, Large | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Extra Large Cuff (0, -2, -1, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Regular, Large, Extra Large | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Extra Large Cuff (0, -1, -2, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Large, Regular, Extra Large | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Extra Large Cuff (-1, 0, -2, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Extra Large, Regular, Extra Large | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Extra Large Cuff (-1, -2, 0, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Extra Large, Extra Large | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Extra Large Cuff (-2, -1, 0, 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Extra Large, Extra Large | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|
| Other: Extra Large Cuff (-2, 0, -1 0)<br>The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Extra Large, Large, Extra Large | Other: Order of cuff sizes during blood pressure measurements<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in systolic BP in appropriately-sized cuff vs. too small cuff | Difference between (1) 1st systolic BP and (2) average of 3 systolic BP from measurements (mmHg). | Up to 90 minutes | 
| Difference in systolic BP in appropriately-sized cuff vs. too large cuff | Difference between (1) 1st systolic BP and (2) average of 3 systolic BP from measurements (mmHg). | Up to 90 minutes | 
| Difference in diastolic BP in appropriately-sized cuff vs. too small cuff | Difference between (1) 1st diastolic BP and (2) average of 3 diastolic BP from measurements (mmHg). | Up to 90 minutes | 
| Difference in diastolic BP in appropriately-sized cuff vs. too large cuff | Difference between (1) 1st diastolic BP and (2) average of 3 diastolic BP from measurements (mmHg). | Up to 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in blood pressure based on hypertension status | To determine the blood pressure difference based on hypertensive (≥140/90 based on triplicate measures using appropriately sized cuff) vs. non-hypertensive participants. | Up to 90 minutes | 
| Difference in blood pressure based on arm circumference | To determine the blood pressure difference based on arm circumference (continuous). | Up to 90 minutes | 
| Difference in blood pressure based on BMI | 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). | Up to 90 minutes |