Pleth Variability Index and Fluid Management During Surgery | NCT00816153

Studies
Pleth Variability Index and Fluid Management During Surgery

NCT00816153

Sponsor

Université Catholique de Louvain

Status

Completed

Last Update Posted

Dec 31, 2008Estimated

Enrollment

97Actual

Phase

Not Applicable

Conditions

Fluid Management

Interventions

PVI-guided fluid management

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Dec 30, 2008

First Submission Date that Met QC Criteria

Dec 30, 2008

First Posted Date

Dec 31, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2008

Last Update Posted Date

Dec 31, 2008Estimated

Name	Class
Masimo Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PVI	Experimental	PVI guided fluid management	Other: PVI-guided fluid management
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PVI-guided fluid management	Other	Peroperative comparison of standard care with PVI-guided fluid management (optimization of the PVI value with fluid loading)	PVI

Measure	Description	Time Frame
Hemodynamics and derived-parameters		The first 48 h

Measure	Description	Time Frame
All causes of morbi-mortality

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Major abdominal surgery

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St-Luc Hospital		Brussels		1200	Belgium