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CompletedNCT02271841Updated Apr 28, 2021

How Are Changing the Practices After the Introduction of the Pleth Variability Index? A Before/After Survey.

An observational study in Fluid Management, sponsored by Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-28.

Sponsored by Université Catholique de Louvain · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
88
Ages
18 Years and older
Sex
All
01

Study summary

This study evaluated the practice before and after the introduction of a particular model pulsoxymeter giving, in addition, information on the state of fluid responsiveness of the patient.

Read the detailed description

This study aims to qualify the capability of general anesthesiologist to adopt Pleth Variability Index (PVI) into their practice. It also seeks to establish whether the introduction of the PVI in the clinical practice is associated with a modification of the practice. In this scope, the intent is to see the impact of introduction of PVI monitoring on anesthesiologist practices, and to do this by comparing their survey response both before and after use of PVI in their surgeries, and to see how clinical practices for GDT and outcomes may have changed. To that end, the intent is to conduct this at sites with no current experience in use of PVI parameter, so that one can closely follow the change in clinician practice as PVI is adopted.

02

Conditions studied

  • Fluid Management
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In context

Lead sponsor

Université Catholique de Louvain is the lead sponsor of 144 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The plan will seek to recruit a minimum of 3 centers in Belgium and/or France who have little to no prior PVI experience, each institution requiring about a minimum of 10 participating anesthesiologists for that institution. As it may be difficult to locate a center without Masimo technology, the goal is to locate a center not actively in use with PVI technology for managing fluid responsiveness, and the clinicians are not actively consulting with Masimo

Inclusion criteria

  • Patients over 18 years
  • ASA 1 to 3

Exclusion criteria

Exclusion Criteria:

  • ASA 4
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
88 participants (actual)
Patient registry
No

Groups and cohorts

  • Before introduction of PVI

    Physicians' practices

  • After introduction of PVI

    Physicians' practices

    Device: PVI

Interventions

  • DevicePVI

    Pleth Variability Index

06

What researchers measure

Primary outcomes

  1. Practice concerning fluid management

    Amounts and type of fluids administered.

    Time frame: One day

Secondary outcomes

  1. Fluid management by center

    Amounts and type of fluids administered.

    Time frame: One day

  2. Mortality after the introduction of Pleth Variability Index

    mortality is higher in one of the two groups?

    Time frame: 30 days after surgery

Other outcomes

  1. Fluid management in the elderly person in belgium

    Amounts and type of fluids administered.

    Time frame: One day

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Study locations

1 site
  • Cliniques universitaires Saint-Luc
    Brussels, 1200, Belgium
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02271841
Lead sponsor
Université Catholique de Louvain
Collaborators
Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel
Responsible party
Patrice Forget (M.D., Ph.D., Universitair Ziekenhuis Brussel) — Principal investigator
First posted
Oct 22, 2014
Start date
Oct 2014
Primary completion
Dec 2018
Completion
Dec 2018
Last update
Apr 28, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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