Nexfin®-Monitoring System
Electronic Registration of Noninvasively Acquired Hemodynamic Parameters Using Nexfin®-Monitoring System
1 other identifier
observational
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 25, 2011
CompletedFirst Posted
Study publicly available on registry
May 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedApril 17, 2024
April 1, 2024
4 months
May 25, 2011
April 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
patients, that are having a routine surgical procedure.
Eligibility Criteria
Adult patients, that are having a routine surgical procedure.
You may qualify if:
- Patients that are accepted for surgery
You may not qualify if:
- Patients unable or unwilling to provide consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Groningen
Groningen, 9713GZ, Netherlands
Related Publications (1)
Vos JJ, Poterman M, Mooyaart EA, Weening M, Struys MM, Scheeren TW, Kalmar AF. Comparison of continuous non-invasive finger arterial pressure monitoring with conventional intermittent automated arm arterial pressure measurement in patients under general anaesthesia. Br J Anaesth. 2014 Jul;113(1):67-74. doi: 10.1093/bja/aeu091. Epub 2014 Apr 15.
PMID: 24740992DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Alain F Kalmar, Dr.
University Medical Center Groningen
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2011
First Posted
May 30, 2011
Study Start
May 1, 2011
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
April 17, 2024
Record last verified: 2024-04