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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 24, 2014