Body Structures Determining Differences in Forearm and Upper Arm Blood Pressures
2012年11月6日 更新者:Christiana Care Health Services
Anatomical Determinants of Forearm and Upper Arm Oscillometric Blood Pressure Differences
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.
研究概览
地位
完全的
条件
详细说明
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.
研究类型
观察性的
注册 (实际的)
51
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Delaware
-
Newark、Delaware、美国、10718
- Christiana Hospital
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-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
patients undergoing non-emergent cardiac catheterization
描述
Inclusion Criteria:
- 18 years of age
- able to speak and write in English
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 观测模型:仅案例
- 时间观点:预期
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
anatomical determinants of forearm and upper arm blood pressure differences
大体时间:6 months
|
body mass index, upper arm circumference, biceps skin-fold measurement, forearm and upper arm vessel diameter, forearm and upper arm vessel depth
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
blood pressure differences; quantitative model of waveform propagation and reflection able to predict differences between upper arm and forearm blood pressures
大体时间:6 months
|
blood pressure at forearm, upper arm, aortic root radial artery tonometry to determine radial artery waveform and pressure measurements non-invasively |
6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Kathleen A Schell, PhD、University of Delaware
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Schell K, Lyons D, Bradley E, Bucher L, Seckel M, Wakai S, Carson E, Waterhouse J, Chichester M, Bartell D, Foraker T, Simpson EK. Clinical comparison of automatic, noninvasive measurements of blood pressure in the forearm and upper arm with the patient supine or with the head of the bed raised 45 degrees: a follow-up study. Am J Crit Care. 2006 Mar;15(2):196-205.
- Schell K, Bradley E, Bucher L, Seckel M, Lyons D, Wakai S, Bartell D, Carson E, Chichester M, Foraker T, Simpson K. Clinical comparison of automatic, noninvasive measurements of blood pressure in the forearm and upper arm. Am J Crit Care. 2005 May;14(3):232-41.
- Schell K, Morse K, Waterhouse JK. Forearm and upper-arm oscillometric blood pressure comparison in acutely ill adults. West J Nurs Res. 2010 Apr;32(3):322-40. doi: 10.1177/0193945909351887.
- Schell K, Waterhouse,JK. Comparison of forearm and upper arm automatic noninvasive blood pressures in college students. Internet Journal of Advanced Nursing Practice 2007, 9 (1): 10 pages
- Schell KA, Richards JG, Farquhar WB. The effects of anatomical structures on adult forearm and upper arm noninvasive blood pressures. Blood Press Monit. 2007 Feb;12(1):17-22. doi: 10.1097/MBP.0b013e3280858cd0.
- Rose WC, Johnson DA, Spaeth JR, Edwards J, Beris, AN. Computational and experimental investigation of arterial hemodynamics. Proc. 2008 Int. Mech. Eng. Conf. Exp. Boston: ASME, 2008; 1-8.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年3月1日
初级完成 (实际的)
2012年3月1日
研究完成 (实际的)
2012年8月1日
研究注册日期
首次提交
2010年3月8日
首先提交符合 QC 标准的
2010年3月15日
首次发布 (估计)
2010年3月16日
研究记录更新
最后更新发布 (估计)
2012年11月7日
上次提交的符合 QC 标准的更新
2012年11月6日
最后验证
2012年11月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- CCC29150
- NURS175154 (其他标识符:University of Delaware IRB)
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.