ARMS: The Arm Rest and Support Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Difference of systolic and diastolic differences
研究概览
简要总结
Primary Objectives
- Determine the effect of an unsupported and poorly positioned arm on initial and average triplicate blood pressure done according to clinical practice guidelines with an automated device.
a. Hypothesis: Compared to blood pressure measurements obtained with the arm supported with mid-cuff positioned at heart level, blood pressures measured with an unsupported arm and/or with mid-cuff below heart level will be significantly higher.
Secondary Objective
- To determine if the effects differ based on the following patient characteristics:
- Hypertensive blood pressure (SBP≥130 mmHg vs. <130 mmHg).
- Age (≥ 60 years vs. < 60 years) Greater vascular stiffness > lesser vascular stiffness
- Regular health care (Last BP measured >1 year ago vs. ≤1 year ago)
- Arm length:cuff width
详细描述
The investigators propose a cross-sectional study of adult participants recruited from the community. Enrolled participants will have four sets of three automated blood pressure measurements, with each set taken with the arm positioned and supported as follows:
-
Arm supported on a desk, with mid-cuff at mid-heart level (4th intercostal space)
-
Desk1
-
Reference measurement
-
Arm supported on the participant's lap
-
Lap
-
Arm hanging at the participant's side, unsupported
-
Side
-
The last period of triplicate BP measurements will always have the arm supported and mid-cuff positioned at mid-heart level
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
- •Age ≥ 18 years
排除标准
- •Presence of the following on both arms: rashes, gauze dressings, casts, edema, paralysis, tubes, open sores or wounds, A-V shunts.
- •Being mentally impaired
- •Being pregnant
- •Arm circumference exceeding 55 cm.
- •>80 years of age
结局指标
主要结局
Difference of systolic and diastolic differences
时间窗: Time of measurement up to 90 minutes
Systolic and Diastolic BP difference of differences between: (Desk1-Desk2) and (Lap-Desk1) from measurements (mmHg)
Difference of diastolic differences
时间窗: Time of measurement up to 90 minutes
Systolic and Diastolic Difference of differences in BP measurements (mmHg) between: (Desk1-Desk2) and (Side-Desk1)
Difference in systolic blood pressure in lap1 vs desk arm position
时间窗: Time of measurement up to 90 minutes
Absolute difference between (1) 1st systolic BP and (2) average of 3 systolic BP from measurements (mmHg) obtained in: Lap vs Desk1
Difference in diastolic blood pressure in side vs desk 1 arm position
时间窗: Time of measurement up to 90 minutes
Absolute difference between (1) 1st diastolic BP and (2) average of 3 diastolic BP from measurements (mmHg) obtained with: Side vs Desk1
次要结局
- Difference in blood pressure based on age(Time of measurement up to 90 minutes)
- Difference in blood pressure based on regular healthcare visits(Time of measurement up to 90 minutes)
- Difference in blood pressure based on arm length to cuff width ratio(Time of measurement up to 90 minutes)
- Difference in blood pressure based on hypertension status(Time of measurement up to 90 minutes)