Accuracy of Nexfin® and NIBP to Predict IBP

Evolution of the Accuracy of the Nexfin Pressure Signal Compared to Invasive and Noninvasive Arterial Blood Pressure

The Nexfin monitoring device relies on noninvasive pressure measurement using a finger-cuff manometer, combined with NIRS technology. The accuracy of the signal is dependent on the degree of vascular unloading, which takes an period before optimal unloading is reached. The evolution of the degree of inaccuracy caused by inclomplete unloading is quantified, and the absolute and relative inaccuracy of the nexfin as a function of the time is determined compared to the invasive blood pressure (IBP).

Secondly, the accuracy of the Nexfin to predict the IBP is compared with the accuracy of noninvasive blood pressure to predict the IBP.

Study Overview

• Status: Completed
• Conditions: Bloodpressure

Detailed Description

In patients under stable anesthesia conditions, who have IBP and NIBP monitoring, the Nexfin will additionaly be connected. All data will be recorded for at least 30 minutes. NIBP will be measured every 5 minutes The evolution of the NIBP, IBP and Nexfin-derived blood pressure will be analysed to determine the evolution of inaccuracy due to incomplete vascular unloading and to determine the accuracy of Nexfin compared with NIBP to determine IBP.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713EZ
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

120 Adult patients, that are having a routine surgical procedure.

Description

Inclusion Criteria:

• Patients that are accepted for surgery

Exclusion Criteria:

• Patients unable or unwilling to provide consent.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
surgical patients; 120 Adult patients, that are having a routine surgical procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vascular unloading time	time to optimal vascular unloading	Start till end of operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bloodpressure	accuracy of nexfin compared to NIBP and IBP	Start till end of operation

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Alain Kalmar, dr, univertsity medical center groningen,university of groningen,the netherlands

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: May 23, 2013
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (Estimated): January 16, 2014

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Nexfin_002