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Pleth Variability Index and Fluid Management During Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00816153
First Posted: December 31, 2008
Last Update Posted: December 31, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Masimo Corporation
Information provided by:
Université Catholique de Louvain
  Purpose
Pleth Variability Index (PVI) seems to be an ideal parameter to guide fluid management: dynamic parameter and non-invasive. PVI could guide fluid management during surgery and optimization of the plethysmographic-derived parameter could improve hemodynamics of the patients.

Condition Intervention
Fluid Management Other: PVI-guided fluid management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is Pleth Variability Index Able to Guide Fluid Management During Surgery?

Further study details as provided by Université Catholique de Louvain:

Primary Outcome Measures:
  • Hemodynamics and derived-parameters [ Time Frame: The first 48 h ]

Secondary Outcome Measures:
  • All causes of morbi-mortality

Enrollment: 97
Study Start Date: March 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PVI
PVI guided fluid management
Other: PVI-guided fluid management
Peroperative comparison of standard care with PVI-guided fluid management (optimization of the PVI value with fluid loading)
No Intervention: Control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major abdominal surgery

Exclusion Criteria:

  • Refusal or inability to understand the protocol
  • Arrythmia
  • <18 years
  • Contraindication to normal mechanical ventilation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816153


Locations
Belgium
St-Luc Hospital
Brussels, Belgium, 1200
Sponsors and Collaborators
Université Catholique de Louvain
Masimo Corporation
  More Information

Responsible Party: Forget Patrice, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT00816153     History of Changes
Other Study ID Numbers: 2008/1
First Submitted: December 30, 2008
First Posted: December 31, 2008
Last Update Posted: December 31, 2008
Last Verified: December 2008

Keywords provided by Université Catholique de Louvain:
Pleth variability Index
Fluid management
Fluid management during surgery