Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery

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

PHASE3

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-11-30

Brief Summary

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The purpose of this study is to determine whether an operative hemodynamic optimization using the plethysmographic variability index during orthopedic surgery could decrease the length of hospital stay and the postoperative morbidity.

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Detailed Description

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Conditions

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Hip Arthroplasty Knee Arthroplasty General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PVI group

Fluid optimisation using PVI

Group Type OTHER

Plethysmographic variability index

Intervention Type DEVICE

Control group

Standard care using a hemodynamic protocol during general anesthesia

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Plethysmographic variability index

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Indication to a knee or hip arthroplasty under general anesthesia
* Sinusal rhythm

* Pregnant women
* Black skin
* Dialysis
* Cardiac arrythmia
* Sepsis
* Use of another hemodynamic monitoring during surgery

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No