How Are Changing the Practices After the Introduction of the Pleth Variability Index? A Before/After Survey.
1 other identifier
observational
88
1 country
1
Brief 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.
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 Oct 2014
Longer than P75 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
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 6, 2014
CompletedFirst Posted
Study publicly available on registry
October 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedApril 28, 2021
April 1, 2021
4.2 years
October 6, 2014
April 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Practice concerning fluid management
Amounts and type of fluids administered.
One day
Secondary Outcomes (2)
Fluid management by center
One day
Mortality after the introduction of Pleth Variability Index
30 days after surgery
Other Outcomes (1)
Fluid management in the elderly person in belgium
One day
Study Arms (2)
Before introduction of PVI
Physicians' practices
After introduction of PVI
Physicians' practices
Interventions
Eligibility Criteria
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
You may qualify if:
- Patients over 18 years
- ASA 1 to 3
You may not qualify if:
- ASA 4
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Université Catholique de Louvainlead
- Universitair Ziekenhuis Brusselcollaborator
- Vrije Universiteit Brusselcollaborator
Study Sites (1)
Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Ph.D.
Study Record Dates
First Submitted
October 6, 2014
First Posted
October 22, 2014
Study Start
October 1, 2014
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
April 28, 2021
Record last verified: 2021-04