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Nexfin®-Monitoring System

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ClinicalTrials.gov Identifier: NCT01362335
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : January 16, 2013
Sponsor:
Information provided by (Responsible Party):
A.F.Kalmar, University Medical Center Groningen

Brief 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.


Condition or disease
Surgery

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Study Type : Observational
Actual Enrollment : 120 participants
Time Perspective: Prospective
Official Title: Electronic Registration of Noninvasively Acquired Hemodynamic Parameters Using Nexfin®-Monitoring System
Study Start Date : May 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Group/Cohort
patients, that are having a routine surgical procedure.



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713GZ
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: Alain F Kalmar, Dr. University Medical Center Groningen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: A.F.Kalmar, dr, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01362335    
Other Study ID Numbers: Nex-001
First Posted: May 30, 2011    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013