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Completed

NCT Number: NCT07024472

NIBP Cuff Comparison Study

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

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Key information

Conditions

Blood Pressure Blood Pressure Measurement

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Metropolia University of Applied Sciencies, Helsinki, Finland

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 18 years to 65 years
  • Are able and willing to comply with the study procedures.
  • Are able and willing to provide written informed consent to participate.
  • A cuff of same size is applicable to both arms (difference between the limbs should be less than 2cm)
  • Blood pressure needs to be measurable from both arms.

Exclusion criteria

  • Are pregnant.
  • Are breastfeeding.
  • Have participated in the study. No subject may participate more than once.
  • Have an AV fistula.
  • Have acute infection.
  • Have subject reported arrythmias.
  • PI or designee decision due to subject health conditions

Treatment and study plan

Primary outcomes

  1. Primary Outcome Measure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study title

NIBP Cuff Material Comparison Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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