Body Structures Determining Differences in Forearm and Upper Arm Blood Pressures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01087827

Recruitment Status : Completed

First Posted : March 16, 2010

Last Update Posted : November 7, 2012

Sponsor:

Collaborator:

University of Delaware

Information provided by (Responsible Party):

Christiana Care Health Services

Study Description

Brief Summary:

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.

Condition or disease
Blood Pressure

Detailed Description:

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.

Study Design

Layout table for study information

Study Type :	Observational
Actual Enrollment :	51 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Anatomical Determinants of Forearm and Upper Arm Oscillometric Blood Pressure Differences
Study Start Date :	March 2010
Actual Primary Completion Date :	March 2012
Actual Study Completion Date :	August 2012

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

anatomical determinants of forearm and upper arm blood pressure differences [ Time Frame: 6 months ]
body mass index, upper arm circumference, biceps skin-fold measurement, forearm and upper arm vessel diameter, forearm and upper arm vessel depth

Secondary Outcome Measures :

blood pressure differences; quantitative model of waveform propagation and reflection able to predict differences between upper arm and forearm blood pressures [ Time Frame: 6 months ]
blood pressure at forearm, upper arm, aortic root

radial artery tonometry to determine radial artery waveform and pressure measurements non-invasively

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

patients undergoing non-emergent cardiac catheterization

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087827

Locations

Layout table for location information

United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 10718

Sponsors and Collaborators

Christiana Care Health Services

University of Delaware

Investigators

Layout table for investigator information

Principal Investigator:	Kathleen A Schell, PhD	University of Delaware

More Information

Publications:

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.

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.

Layout table for additonal information

Responsible Party:	Christiana Care Health Services
ClinicalTrials.gov Identifier:	NCT01087827
Other Study ID Numbers:	CCC29150 NURS175154 ( Other Identifier: University of Delaware IRB )
First Posted:	March 16, 2010 Key Record Dates
Last Update Posted:	November 7, 2012
Last Verified:	November 2012

Keywords provided by Christiana Care Health Services:


oscillometric blood pressure cuff site forearm blood pressure upper arm blood pressure	anthropometric measurements tonometry site of blood pressure measurement measurement accuracy

To Top