Healthy VolunteersNCT01753895
Mercury Versus Automated Blood Pressure Monitoring
An observational study of Healthy Volunteers, run by Rockefeller University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University
New York, New York, 10065
About this study
Official title: Comparison of Manual Blood Pressure Monitoring Using a Mercury Sphygmomanometer to an Automated Blood Pressure Instrument in a Research Setting
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 outpatient visit and data will be analyzed at study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arlene Hurley, Rockefeller University
- Investigators
- Arlene Hurley, MA, ANP, CCRC, Principal investigator, The Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753895
- Sponsor's protocol ID
- AHU-0759
- Status last verified
- May 2014
- First submitted
- 5 Dec 2012
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Manual Blood Pressure Monitoring Using a Mercury Sphygmomanometer to an Automated Blood Pressure Instrument in a Research Setting
- ClinicalTrials.gov ID
- NCT01753895
- Acronym / sponsor ID
- AHU-0759
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
This study will assess any differences in blood pressure readings noted between standard brachial blood pressure measurement and wrist-mounted radial blood pressure measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arlene Hurley, MA, ANP, CCRC principal investigator
The Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Rockefeller University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2014.