NCT02271841

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

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 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

October 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

4.2 years

First QC Date

October 6, 2014

Last Update Submit

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

Device: PVI

Interventions

PVIDEVICE

Pleth Variability Index

After introduction of PVI

Eligibility Criteria

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

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

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

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

Locations