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

Fluid Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271841
• Other study ID #: UCLouvain
• Status: Completed
• Start date: October 2014
• Est. completion date: December 2018

Study information

• Verified date: April 2021
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years

• ASA 1 to 3

Exclusion Criteria:

• ASA 4

Related Conditions & MeSH terms

• Fluid Management

Intervention

Device:
• PVI
Pleth Variability Index

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels

Sponsors (3)

Lead Sponsor	Collaborator
Université Catholique de Louvain	Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fluid management in the elderly person in belgium	Amounts and type of fluids administered.	One day
Primary	Practice concerning fluid management	Amounts and type of fluids administered.	One day
Secondary	Fluid management by center	Amounts and type of fluids administered.	One day
Secondary	Mortality after the introduction of Pleth Variability Index	mortality is higher in one of the two groups?	30 days after surgery