NCT02038270

Brief Summary

The Nexfin monitoring device relies on noninvasive pressure measurement using a finger-cuff manometer, combined with NIRS technology. The accuracy of the signal is dependent on the degree of vascular unloading, which takes an period before optimal unloading is reached. The evolution of the degree of inaccuracy caused by inclomplete unloading is quantified, and the absolute and relative inaccuracy of the nexfin as a function of the time is determined compared to the invasive blood pressure (IBP). Secondly, the accuracy of the Nexfin to predict the IBP is compared with the accuracy of noninvasive blood pressure to predict the IBP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2013

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

May 23, 2013

Last Update Submit

April 16, 2024

Conditions

Bloodpressure

Outcome Measures

Primary Outcomes (1)

  • vascular unloading time

    time to optimal vascular unloading

    Start till end of operation

Secondary Outcomes (1)

  • Bloodpressure

    Start till end of operation

Study Arms (1)

surgical patients

120 Adult patients, that are having a routine surgical procedure.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

120 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, 9713EZ, Netherlands

Location

Study Officials

  • Alain Kalmar, dr

    univertsity medical center groningen,university of groningen,the netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2013

First Posted

January 16, 2014

Study Start

September 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

April 18, 2024

Record last verified: 2024-04

Locations

NL(1)