Accuracy of Pleth Variability Index (PVI) in Children

Completed

• Conditions: Scoliosis

• Registration Number: NCT01820845
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Plethysmographic Variability index is a simple index accurate in predicting fluid responsiveness.

The aim of this study was to investigate its accuracy in predicting fluid response to intravenous fluid challenge during scoliosis surgery in children.

Detailed Description

The goal of the present study is to assess the validity of PVI in predicting the response to a fluid challenge during scoliosis surgery in children.

During this observational non-interventional study, each fluid challenge will be monitored by esophageal Doppler and PVI (Massimo Radical 5).

Anesthesia, surgery and intraoperative fluid administration id standardized according to our clinical protocol.

An increase in indexed Stroke Volume (iSV) by more than 15 % will define the positive response to the fluid challenge.

Fluid challenges will be performed in the supine position and in the prone position.

Statistical analysis will performed using the Receiving Operator Characteristics (ROC) curve with determination of the gray-zone allowing an error tolerance of 10 %.

Study Timeline

• Status Verified: 2012-12
• Study Start: 2012-12
• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-03-29
• Primary Completion: 2013-12
• Study Completion: 2014-06
• Last Update Submitted: 2014-12-03
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Scoliosis surgery
• Age < 18 years

Exclusion Criteria

• Heart or vascular Diseases
• Rectal abnormalities
• Kidney Failure
• Neuromuscular scoliosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plethysmographic Variability before each fluid challenge and percentage of variation in Indexed Stroke Volume during each fluid challenge.	During the intraoperative period.	Data will be used to assess the accuracy of Plethysmographic Variability Index in predicting fluid challenge.

Secondary Outcome Measures

Name	Time	Method
Indexed Stroke volume before each fluid challenge and percentage of variation in indexed Stroke volume during each fluid challenge.	During the intraoperative period	Data will be used to assess the accuracy of indexed Stroke volume in predicting the response to fluid challenge.

Trial Locations

Locations (1)

Department of Anesthesiology, Robert Debre University Hospital; 🇫🇷 Paris, France