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

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.

Study Overview

• Status: Completed
• Conditions: Fluid Management
• Intervention / Treatment: Device: PVI

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.

• Study Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• Patients over 18 years
• ASA 1 to 3

Exclusion Criteria:

• ASA 4

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Before introduction of PVI; Physicians' practices
After introduction of PVI; Physicians' practices	Device: PVI; Pleth Variability Index

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Practice concerning fluid management	Amounts and type of fluids administered.	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid management by center	Amounts and type of fluids administered.	One day
Mortality after the introduction of Pleth Variability Index	mortality is higher in one of the two groups?	30 days after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid management in the elderly person in belgium	Amounts and type of fluids administered.	One day

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Collaborators: Universitair Ziekenhuis Brussel; Vrije Universiteit Brussel

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: October 6, 2014
• First Submitted That Met QC Criteria: October 20, 2014
• First Posted (Estimate): October 22, 2014

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: UCLouvain