Hypertension
Conditions
Keywords
Hypertension, Hypotension
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.
Interventions
DEVICEBlood pressure measurement
Sponsors
Maaynei Hayesha Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Israel
Contacts
Primary ContactMordchai Ravid, MD FACP
Backup ContactItzhak Klinger, MD
Outcome results
None listed