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Pleth Variability Index and Fluid Management During Surgery

NCT ID: NCT00816153

Last Updated: 2008-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-08-31

Brief Summary

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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

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Conditions

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Fluid Management

Keywords

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Pleth variability Index Fluid management Fluid management during surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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PVI

PVI guided fluid management

Group Type EXPERIMENTAL

PVI-guided fluid management

Intervention Type OTHER

Peroperative comparison of standard care with PVI-guided fluid management (optimization of the PVI value with fluid loading)

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PVI-guided fluid management

Peroperative comparison of standard care with PVI-guided fluid management (optimization of the PVI value with fluid loading)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Major abdominal surgery

Exclusion Criteria

* Refusal or inability to understand the protocol
* Arrythmia
* \<18 years
* Contraindication to normal mechanical ventilation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Masimo Corporation

INDUSTRY

Sponsor Role collaborator

Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Université Catholique de Louvain

Locations

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St-Luc Hospital

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2008/1

Identifier Type: -

Identifier Source: org_study_id