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Body Structures Determining Differences in Forearm and Upper Arm Blood Pressures

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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

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.

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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



Primary Outcome Measures :
  1. 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 :
  1. 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




Information from the National Library of Medicine

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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

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
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United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 10718
Sponsors and Collaborators
Christiana Care Health Services
University of Delaware
Investigators
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Principal Investigator: Kathleen A Schell, PhD University of Delaware
Publications:
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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