Cuff(SZ): The Cuff Size Blood Pressure Measurement Trial
Study Details
Study Description
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:
-
Hypertensive (≥140/90 based on triplicate measures using appropriately sized cuff) vs. non-hypertensive.
-
Arm circumference (continuous)
-
Obesity status
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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)
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Small Cuff (0, +1, +2, 0) 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
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.
|
| Other: Small Cuff (0, +2, +1, 0) 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
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.
|
| Other: Small Cuff ( +1, 0, +2, 0) 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
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.
|
| Other: Small Cuff ( +1, +2, 0, 0) 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
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.
|
| Other: Small Cuff ( +2, 0, +1, 0) 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
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.
|
| Other: Small Cuff ( +2, +1, 0, 0) 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
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.
|
| Other: Regular Cuff (0, -1, +1, 0) 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
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.
|
| Other: Regular Cuff (0, +1, -1, 0) 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
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.
|
| Other: Regular Cuff (-1, 0, +1, 0) 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
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.
|
| Other: Regular Cuff (-1, +1, 0, 0) 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
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.
|
| Other: Regular Cuff (+1, -1, 0, 0) 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
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.
|
| Other: Regular Cuff (+1, 0, -1, 0) 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
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.
|
| Other: Large Cuff (-1, 0, +1, 0) 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
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.
|
| Other: Large Cuff (-1, +1, 0, 0) 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
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.
|
| Other: Large Cuff (0, +1, -1, 0) 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
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.
|
| Other: Large Cuff (0, -1, +1, 0) 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
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.
|
| Other: Large Cuff (+1, 0, -1, 0) 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
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.
|
| Other: Large Cuff (+1, -1, 0, 0) 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
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.
|
| Other: Extra Large Cuff (0, -2, -1, 0) 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
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.
|
| Other: Extra Large Cuff (0, -1, -2, 0) 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
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.
|
| Other: Extra Large Cuff (-1, 0, -2, 0) 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
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.
|
| Other: Extra Large Cuff (-1, -2, 0, 0) 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
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.
|
| Other: Extra Large Cuff (-2, -1, 0, 0) 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
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.
|
| Other: Extra Large Cuff (-2, 0, -1 0) 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
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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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).
Eligibility Criteria
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.
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Being mentally impaired, pregnant.
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Arm circumference exceeding 50 cm.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins ProHealth Research Center | Baltimore | Maryland | United States | 21207 |
Sponsors and Collaborators
- Johns Hopkins University
- Vital Strategies
Investigators
- Principal Investigator: Tammy Brady, MD,Phd, Johns Hopkins University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00252142