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临床试验/NCT01087827
NCT01087827已完成不适用

Anatomical Determinants of Forearm and Upper Arm Oscillometric Blood Pressure Differences

Christiana Care Health Services1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
anatomical determinants of forearm and upper arm blood pressure differences

研究概览

简要总结

The first purpose of this study is to see how blood pressures taken at different sites, specifically the forearm, upper arm and heart vessels, are different. The second purpose is to see if body structures such as vessel size and depth, size of the arm, and amount of tissue in the arm influence differences in blood pressures taken at these sites. The third purpose is to develop a mathematical model of the waves generated by the arm arteries (brachial and radial) to predict differences in forearm and upper arm blood pressures. The results of the study may be used to design more accurate non-invasive blood pressure monitors for the forearm site.

详细描述

Accurate blood pressure (BP) measurement is required to provide appropriate healthcare. Inaccurate BPs may lead to under and/or over-treatment of health conditions and medical diseases such as hypertension. Blood pressure (BP) measurement using automatic, non-invasive oscillometric monitors is common in clinics, physicians'offices and hospital settings. The brachial (upper arm) site is the gold standard for non-invasive BPs. However, in some situations, this site is inaccessible due to injury, surgery, dialysis shunts, intravenous devices, and lymphedema. When the upper arm is difficult to access or the available BP cuffs do not fit an individual's arm, the forearm site is often the preferable alternative. The increased incidence of obesity nationally also contributes to the heightened use of forearm BPs. Questions remain concerning the accuracy of forearm non-invasive BP measurements. Although most researchers report that upper arm and forearm readings are not interchangeable, size of differences vary for individuals and factors influencing differences in readings have not been thoroughly investigated.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age
  • able to speak and write in English

排除标准

  • Individuals with non-intact skin where the BP cuffs would be placed
  • Individuals with injury or surgery to the arm within the last month
  • Individuals with lymphedema in the limb selected for measurements
  • Individuals with arteriovenous fistulas
  • Individuals with differences > 5 mm Hg between right and left arm oscillometric systolic BP measurements
  • Individuals with documented valvular disease
  • Individuals with atrial fibrillation or atrial flutter (as recommended by BP device manufacturers due to device inaccuracy)
  • Individuals with an International Normalized Ratio (INR) > 1.7
  • Individuals with intravenous catheters in both arms
  • Individuals who require immediate cardiac surgery or unanticipated emergency treatment or who are unstable during the procedure

结局指标

主要结局

anatomical determinants of forearm and upper arm blood pressure differences

时间窗: 6 months

body mass index, upper arm circumference, biceps skin-fold measurement, forearm and upper arm vessel diameter, forearm and upper arm vessel depth

次要结局

  • blood pressure differences; quantitative model of waveform propagation and reflection able to predict differences between upper arm and forearm blood pressures(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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