Evaluation of a New Blood Pressure Measuring Device.
- Conditions
- Hypertension
- Registration Number
- NCT00265707
- Lead Sponsor
- Maaynei Hayesha Medical Center
- Brief Summary
* 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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- Male or female, age 18 years or above
- Signed written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The difference between the paired measurements with the tested device and the reference measurements (with a mercury sphygmomanometer) will differ by no more than +-5mmHg.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Medicine, Maaynei Hayesha Hospital
🇮🇱Tel Aviv, Israel