The Cuff Size Blood Pressure Measurement Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Difference in systolic BP in appropriately-sized cuff vs. too small cuff
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (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
干预措施: Order of cuff sizes during blood pressure measurements (Other)
结局指标
主要结局
Difference in systolic BP in appropriately-sized cuff vs. too small cuff
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Up to 90 minutes
Difference between (1) 1st diastolic BP and (2) average of 3 diastolic BP from measurements (mmHg).
次要结局
- Difference in blood pressure based on hypertension status(Up to 90 minutes)
- Difference in blood pressure based on arm circumference(Up to 90 minutes)
- Difference in blood pressure based on BMI(Up to 90 minutes)