Nexfin®-Monitoring System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
A.F.Kalmar, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01362335
First received: May 25, 2011
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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.


Condition
Surgery

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)
Groups/Cohorts
patients, that are having a routine surgical procedure.

  Eligibility

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.

Criteria

Inclusion Criteria:

  • Patients that are accepted for surgery

Exclusion Criteria:

  • Patients unable or unwilling to provide consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362335

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

No publications provided by University Medical Centre Groningen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: A.F.Kalmar, dr, University Medical Centre Groningen
ClinicalTrials.gov 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)

ClinicalTrials.gov processed this record on October 23, 2014