Body Structures Determining Differences in Forearm and Upper Arm Blood Pressures

NCT01087827 | Completed

• 2 other identifiers: CCC29150NURS175154
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing non-emergent cardiac catheterization

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christiana Care Health Services: lead
• University of Delaware: collaborator

Study Sites (1)

Christiana Hospital

Newark, Delaware, 10718, United States

Location

Related Publications (6)

• 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.

  PMID: 16501139 BACKGROUND

• 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.

  PMID: 15840897 BACKGROUND

• 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.

  PMID: 20581399 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 17303983 BACKGROUND

• 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.

  BACKGROUND

Study Officials

• Kathleen A Schell, PhD

  University of Delaware

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 16, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 7, 2012

Record last verified: 2012-11

Locations

US (1)