Pleth Variability Index and Fluid Management During Surgery

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. Identifier: NCT00816153
Recruitment Status : Completed
First Posted : December 31, 2008
Last Update Posted : December 31, 2008
Masimo Corporation
Information provided by:
Université Catholique de Louvain

Brief Summary:
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 or disease Intervention/treatment Phase
Fluid Management Other: PVI-guided fluid management Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
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?
Study Start Date : March 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. All causes of morbi-mortality

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

Inclusion Criteria:

  • Major abdominal surgery

Exclusion Criteria:

  • Refusal or inability to understand the protocol
  • Arrythmia
  • <18 years
  • Contraindication to normal mechanical ventilation

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 identifier (NCT number): NCT00816153

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

Responsible Party: Forget Patrice, Université Catholique de Louvain Identifier: NCT00816153     History of Changes
Other Study ID Numbers: 2008/1
First Posted: December 31, 2008    Key Record Dates
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