Mercury Versus Automated Blood Pressure Monitoring

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Arlene Hurley, Rockefeller University
ClinicalTrials.gov Identifier:
NCT01753895
First received: December 5, 2012
Last updated: May 14, 2013
Last verified: December 2012
  Purpose

Blood pressure (BP) measurement is one of the most commonly performed screening tests in the clinical setting. Its accuracy is vital to the early diagnosis and effective management of hypertension, as emphasized by hypertension management guidelines. For most protocols being conducted in a clinical research setting, obtaining single or serial blood pressure reading(s) is often performed as a safety assessment, especially if the individual is participating in a study that requires a blood draw and/or the administration of a research drug, vaccine or device. It is imperative that the blood pressure data truly reflect the response, if any, the study participant experiences in relation to the research procedures and interventions.


Condition
Healthy Volunteers

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Manual Blood Pressure Monitoring Using a Mercury Sphygmomanometer to an Automated Blood Pressure Instrument in a Research Setting

Resource links provided by NLM:


Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Assess difference in blood pressure readings in standard brachial vs. wrist-mounted radial blood pressure measurement [ Time Frame: 1 outpatient visit and data will be analyzed at study completion ] [ Designated as safety issue: No ]
    This study will assess any differences in blood pressure readings noted between standard brachial blood pressure measurement and wrist-mounted radial blood pressure measurement


Estimated Enrollment: 154
Study Start Date: December 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Despite the clear guidelines on manual blood pressure technique, there seems to be large inter-observer variations, both among nursing staff and physicians. These differences are further complicated by variables such as cuff selection and application, incorrect cuff positioning and rapid cuff deflation rate, inadequate rest period, and lack of repeated measurements. The blood pressure measurement obtained by an automated device is not as dependent on observer training and competency as the manual mercury device, yet its use requires careful patient evaluation for caffeine or nicotine use, cuff position, and proper wrist positioning, and instructing the individual not to move or talk if accurate blood pressures are to be obtained. If one performs the automated readings and manual blood pressure measurements under standardized conditions, the mean values will be quite similar; however, this possibility has not yet been fully tested.

Therefore, there is a need to assess systematically if there is in fact a difference in the two blood pressure monitoring approaches under controlled conditions. The goal of this study, then, is to examine our current practice of obtaining manual blood pressure measurement using a mercury sphygmomanometer compared to an automated wrist-mounted blood pressure device.

A possible implication of this study is if the blood pressure measurements using the automated blood pressure device are comparable to the measurements obtained using the mercury sphygmomanometer, than the mercury devices can be replaced by the more environmentally acceptable automated devices in our clinical research setting.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy volunteers

Criteria

Inclusion Criteria:

  • Male or Female >18 and < 100 years of age
  • With or without history of hypertension on or off antihypertensive medications
  • Able to understand the information in the informed consent form and can provide written consent
  • Upper arm and wrist access

Exclusion Criteria:

  • Latex allergy
  • Upper arm circumference > 52mm
  • Wrist circumference < 5 inches and > 8 3/4 inches
  • History of Mastectomy or Upper Extremity Peripheral Vascular Disease
  • History of Carpal Tunnel Disease
  • History of surgical repair of varicosities in the upper arm or wrist
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753895

Locations
United States, New York
The Rockefeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Investigators
Principal Investigator: Arlene Hurley, MA, ANP, CCRC The Rockefeller University
  More Information

No publications provided

Responsible Party: Arlene Hurley, Clinical Research Coordinator, Rockefeller University
ClinicalTrials.gov Identifier: NCT01753895     History of Changes
Other Study ID Numbers: AHU-0759
Study First Received: December 5, 2012
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:
Healthy Volunteers

ClinicalTrials.gov processed this record on April 22, 2014