NIBP Cuff Comparison Study

Completed

• Conditions: Blood Pressure; Blood Pressure Measurement

• Registration Number: NCT07024472
• Lead Sponsor: GE Healthcare

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

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-31
• Study Start: 2025-04-25
• Study First Submitted QC: 2025-06-09
• Study First Posted: 2025-06-17
• Primary Completion: 2025-06-23
• Study Completion: 2025-06-23
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Metropolia University of Applied Sciencies; 🇫🇮 Helsinki, Finland