NIBP Cuff Comparison Study

NIBP Cuff Material Comparison Study

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

Study Overview

• Status: Completed
• Conditions: Blood Pressure Measurement; Blood Pressure

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 Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00920
    • Metropolia University of Applied Sciencies
  • Helsinki, Finland
    • Metropolia University of Applied Sciencies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome Measure	The primary outcome is to collect NIBP measurement data from subjects in laboratory setting to show equivalency of the different NIBP Cuff.	From admission to discharge

Collaborators and Investigators

• Sponsor: GE Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2025
• Primary Completion (Actual): June 23, 2025
• Study Completion (Actual): June 23, 2025

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: June 9, 2025
• First Posted (Actual): June 17, 2025

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 11897689627

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No