New York, New York 10065

  • Healthy Volunteers

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.


Study summary:

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.


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


Study is Available At:


Original ID:

AHU-0759


NCT ID:

NCT01753895


Secondary ID:


Study Acronym:


Brief Title:

Mercury Versus Automated Blood Pressure Monitoring


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Rockefeller University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspectiv


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

156


Enrollment Type:

Actual


Overall Contact Information

Official Name:Arlene Hurley, MA, ANP, CCRC
Principal Investigator
The Rockefeller University

Study Dates

Start Date:December 2012
Completion Date:June 2013
Completion Type:Actual
Primary Completion Date:June 2013
Primary Completion Type:Actual
Verification Date:May 2014
Last Changed Date:May 5, 2014
First Received Date:December 5, 2012

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description:This study will assess any differences in blood pressure readings noted between standard brachial blood pressure measurement and wrist-mounted radial blood pressure measurement

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Rockefeller University

Samples and Retentions

Study Population: Healthy volunteers
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 01, 2021

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