Nexfin®-Monitoring System

Surgery Clinical Trial

Official title:

Electronic Registration of Noninvasively Acquired Hemodynamic Parameters Using Nexfin®-Monitoring System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362335
• Other study ID #: Nex-001
• Status: Completed
• Start date: May 2011
• Est. completion date: September 2011

Study information

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

Clinical Trial Summary

In many surgical procedures, anaesthesiological care is provided according to the best scientific and clinical information available. However, since hemodynamic monitoring until recently did not allow for beat-to-beat information of the haemodynamical changes, many fast-changing events may have been unnoticed or have not been investigated as precisely as is possible today. Moreover, in several surgical procedures - like eye surgery - the invasiveness of the classical haemodynamical monitoring devices was of such a degree that until now, in these circumstances these vital parameters were not investigated yet.

Therefore, the availability of this new device, which allows for noninvasive beat-to-beat assessment of these haemodynamical parameters gives a unique opportunity to investigate our anaesthesiological management and to elucidate whether improvements are desirable and possible.

The Nexfin monitor consists of a cuff-micromanometer that is located around the third finger. It simultaneously uses continuous pressure readings and light-absorption spectrometry to determine valuable haemodynamical information. Data is recorded and available for subsequent offline analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• 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

• Surgery

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	haemodynamical changes after several surgical and anaesthesiological interventions.	Beat-to-beat determination of stroke volume, cardiac output, blood pressure and systemic resistance measurement	30 minutes - 2 hours