We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nexfin®-Monitoring System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01362335
First Posted: May 30, 2011
Last Update Posted: January 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
A.F.Kalmar, University Medical Centre Groningen
  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 A.F.Kalmar, University Medical Centre Groningen:

Primary Outcome Measures:
  • haemodynamical changes after several surgical and anaesthesiological interventions. [ Time Frame: 30 minutes - 2 hours ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362335


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

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
First Submitted: May 25, 2011
First Posted: May 30, 2011
Last Update Posted: January 16, 2013
Last Verified: January 2013


To Top