Accuracy of Nexfin® and NIBP to Predict IBP

Bloodpressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038270
• Other study ID #: Nexfin_002
• Status: Completed
• Start date: September 2011
• Est. completion date: March 2012

Study information

• Verified date: April 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients that are accepted for surgery

Exclusion Criteria:

• Patients unable or unwilling to provide consent.

Related Conditions & MeSH terms

• Bloodpressure

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vascular unloading time	time to optimal vascular unloading	Start till end of operation
Secondary	Bloodpressure	accuracy of nexfin compared to NIBP and IBP	Start till end of operation