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Evaluation of a New Blood Pressure Measuring Device.

NCT ID: NCT00265707

Last Updated: 2006-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2005-12-31

Brief Summary

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* A disposable blood pressure measuring device will be tested and compared to a standard mercury sphygmomanometer.
* Up to 100 subjects with various levels of blood pressure values will be tested.

Detailed Description

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The study will comprise 85 to 100 subjects with blood pressure values ranging between 90 and 170mmHg -systolic and 65-95 -diastolic.

* Three sets of measurements will be performed on each subject. The measurement with the tested device placed between twh determinations with a mercury sphygmomanometer.
* Each measurement will be performed simultaneously by two examiners specially trained.
* Informed consent will be obtained from all participants.
* The results will be evaluated by a standard statistical plan ANSI/AAMI SP-10 2002.

Conditions

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Hypertension

Keywords

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Hypertension Hypotension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Interventions

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Blood pressure measurement

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female, age 18 years or above
* Signed written informed consent

Exclusion Criteria

* A history of cardiac arrythmia
* Wrist circumference smaller than 13cm or larger than 19.5cm
* Documented peripheral vascular disease
* Damage or injury to the left wrist
* Participation in any other clinical study
* Any acute coronary of cardiovascular illness
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maaynei Hayesha Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Mordchai Ravid, MD FACP

Role: PRINCIPAL_INVESTIGATOR

Maaynei Hayesha Hospital

Locations

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Department of Medicine, Maaynei Hayesha Hospital

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Mordchai Ravid, MD FACP

Role: CONTACT

Phone: 972-3-5771113

Email: [email protected]

Itzhak Klinger, MD

Role: CONTACT

Phone: 972-3-5771216

Email: [email protected]

Facility Contacts

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Itzhak Klinger, MD

Role: primary

Other Identifiers

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DPTYN001CTIL

Identifier Type: -

Identifier Source: org_study_id