Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vital Strategies | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Small Cuff (0, +1, +2, 0) | Other | The order of blood pressure cuffs used for participants randomized to this arm will be: Small, Regular, Large, Small |
|
| Small Cuff (0, +2, +1, 0) | Other | The order of blood pressure cuffs used for participants randomized to this arm will be: Small, Large, Regular, Small |
|
| Small Cuff ( +1, 0, +2, 0) | Other | 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) | Other | The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Small, Small |
|
| Small Cuff ( +2, 0, +1, 0) | Other | The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Small, Regular, Small |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Order of cuff sizes during blood pressure measurements | Other | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tammy Brady, MD,Phd | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins ProHealth Research Center | Baltimore | Maryland | 21207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37548984 | Derived | Ishigami J, Charleston J, Miller ER 3rd, Matsushita K, Appel LJ, Brady TM. Effects of Cuff Size on the Accuracy of Blood Pressure Readings: The Cuff(SZ) Randomized Crossover Trial. JAMA Intern Med. 2023 Oct 1;183(10):1061-1068. doi: 10.1001/jamainternmed.2023.3264. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Small Cuff ( +2, +1, 0, 0) | Other | The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Small, Small |
|
| Regular Cuff (0, -1, +1, 0) | Other | The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Small, Large, Regular |
|
| Regular Cuff (0, +1, -1, 0) | Other | The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Small, Regular |
|
| Regular Cuff (-1, 0, +1, 0) | Other | The order of blood pressure cuffs used for participants randomized to this arm will be: Small, Regular, Large, Regular |
|
| Regular Cuff (-1, +1, 0, 0) | Other | 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) | Other | The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Small, Regular, Regular |
|
| Regular Cuff (+1, 0, -1, 0) | Other | The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Small, Regular |
|
| Large Cuff (-1, 0, +1, 0) | Other | 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) | Other | The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Extra Large, Large, Large |
|
| Large Cuff (0, +1, -1, 0) | Other | The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Extra Large, Regular, Large |
|
| Large Cuff (0, -1, +1, 0) | Other | The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Extra Large, Large |
|
| Large Cuff (+1, 0, -1, 0) | Other | The order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Large, Regular, Large |
|
| Large Cuff (+1, -1, 0, 0) | Other | The order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Regular, Large, Large |
|
| Extra Large Cuff (0, -2, -1, 0) | Other | 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) | Other | 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) | Other | The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Extra Large, Regular, Extra Large |
|
| Extra Large Cuff (-1, -2, 0, 0) | Other | 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) | Other | The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Extra Large, Extra Large |
|
| Extra Large Cuff (-2, 0, -1 0) | Other | The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Extra Large, Large, Extra Large |
|
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 |