Nexfin®-Monitoring System

This study has been completed.
Information provided by (Responsible Party):
A.F.Kalmar, University Medical Centre Groningen Identifier:
First received: May 25, 2011
Last updated: January 15, 2013
Last verified: January 2013

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.


Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Electronic Registration of Noninvasively Acquired Hemodynamic Parameters Using Nexfin®-Monitoring System

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • haemodynamical changes after several surgical and anaesthesiological interventions. [ Time Frame: 30 minutes - 2 hours ] [ Designated as safety issue: No ]
    Beat-to-beat determination of stroke volume, cardiac output, blood pressure and systemic resistance measurement

Enrollment: 120
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
patients, that are having a routine surgical procedure.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients, that are having a routine surgical procedure.


Inclusion Criteria:

  • Patients that are accepted for surgery

Exclusion Criteria:

  • Patients unable or unwilling to provide consent.
  Contacts and Locations
Please refer to this study by its identifier: NCT01362335

University Medical Center Groningen
Groningen, Netherlands, 9713GZ
Sponsors and Collaborators
University Medical Centre Groningen
Principal Investigator: Alain F Kalmar, Dr. University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: A.F.Kalmar, dr, University Medical Centre Groningen Identifier: NCT01362335     History of Changes
Other Study ID Numbers: Nex-001
Study First Received: May 25, 2011
Last Updated: January 15, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC) processed this record on April 17, 2014