Evaluation of a New Blood Pressure Measuring Device.

Maaynei Hayesha Medical Center

Status: Unknown

Conditions: Hypertension

Treatments: Device: Blood pressure measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT00265707

DPTYN001CTIL

Details and patient eligibility

About

• 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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind