Mercury Versus Automated Blood Pressure Monitoring

Healthy Volunteers Clinical Trial

Official title:

Comparison of Manual Blood Pressure Monitoring Using a Mercury Sphygmomanometer to an Automated Blood Pressure Instrument in a Research Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753895
• Other study ID #: AHU-0759
• Status: Completed
• Phase: N/A
• First received: December 5, 2012
• Last updated: May 5, 2014
• Start date: December 2012
• Est. completion date: June 2013

Study information

• Verified date: May 2014
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Volunteers

Locations

Country	Name	City	State
United States	The Rockefeller University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Rockefeller University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess difference in blood pressure readings in standard brachial vs. wrist-mounted radial blood pressure measurement	This study will assess any differences in blood pressure readings noted between standard brachial blood pressure measurement and wrist-mounted radial blood pressure measurement	1 outpatient visit and data will be analyzed at study completion	No