NIBP Cuff Comparison Study

General Electric (GE)

Status: Completed

Conditions: Blood Pressure Measurement; Blood Pressure

Study type: Observational

Funder types: Industry

Identifiers

NCT07024472

11897689627

Details and patient eligibility

About

The purpose of the study is to compare NIBP cuff materials and their effect on the measurement results.

Full 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

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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