Blood Pressure, Blood Pressure Measurement
Conditions
Brief summary
The purpose of the study is to compare NIBP cuff materials and their effect on the measurement results.
Detailed description
Non-invasive blood pressure measurement is based on the estimation of blood pressure by using cuffs. Because the accuracy in blood pressure measurement is essential to monitor patients, the reliability of non-invasive sphygmomanometers is required by internationally recognized standards. New NIBP standard ISO 81060-2 AMD2 highlights the impact of cuff materials and construction on NIBP clinical accuracy. This study is designed to gather evidence that different cuffs provide equally comparable NIBP measurement results
Interventions
None listed
Sponsors
GE Healthcare
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age \>= 18 years to 65 years 2. Are able and willing to comply with the study procedures. 3. Are able and willing to provide written informed consent to participate. 4. A cuff of same size is applicable to both arms (difference between the limbs should be less than 2cm) 5. Blood pressure needs to be measurable from both arms.
Exclusion criteria
1. Are pregnant. 2. Are breastfeeding. 3. Have participated in the study. No subject may participate more than once. 4. Have an AV fistula. 5. Have acute infection. 6. Have subject reported arrythmias. 7. PI or designee decision due to subject health conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure | From admission to discharge | The primary outcome is to collect NIBP measurement data from subjects in laboratory setting to show equivalency of the different NIBP Cuff. |
Countries
Finland
Outcome results
None listed