Body Structures Determining Differences in Forearm and Upper Arm Blood Pressures

Blood Pressure Clinical Trial

Official title:

Anatomical Determinants of Forearm and Upper Arm Oscillometric Blood Pressure Differences

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087827
• Other study ID #: CCC29150
• Secondary ID: NURS175154
• Status: Completed
• Phase: N/A
• First received: March 8, 2010
• Last updated: November 6, 2012
• Start date: March 2010
• Est. completion date: August 2012

Study information

• Verified date: November 2012
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Pressure

Locations

Country	Name	City	State
United States	Christiana Hospital	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Christiana Care Health Services	University of Delaware

Country where clinical trial is conducted

United States, 

References & Publications (6)

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anatomical determinants of forearm and upper arm blood pressure differences	body mass index, upper arm circumference, biceps skin-fold measurement, forearm and upper arm vessel diameter, forearm and upper arm vessel depth	6 months	No
Secondary	blood pressure differences; quantitative model of waveform propagation and reflection able to predict differences between upper arm and forearm blood pressures	blood pressure at forearm, upper arm, aortic root; radial artery tonometry to determine radial artery waveform and pressure measurements non-invasively	6 months	No