Pleth Variability Index and Fluid Management During Surgery

This study has been completed.
Sponsor:
Collaborator:
Masimo Corporation
Information provided by:
Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00816153
First received: December 30, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All causes of morbi-mortality [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816153

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

No publications provided

Responsible Party: Forget Patrice, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT00816153     History of Changes
Other Study ID Numbers: 2008/1
Study First Received: December 30, 2008
Last Updated: December 30, 2008
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

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

ClinicalTrials.gov processed this record on April 17, 2014