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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02038270
Other study ID # Nexfin_002
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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