Accuracy of Pleth Variability Index (PVI) in Children

Overview

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.

Full Title of Study: “Accuracy of Pleth Variability Index (PVI) in Predicting Response to Intravenous Fluid Load During Scoliosis Surgery in Children”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2013

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 %.

Arms, Groups and Cohorts

  • Cohort of children with scoliosis surgery

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Scoliosis surgery – Age < 18 years Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor

Citations Reporting on Results

Feldman JM, Sussman E, Singh D, Friedman BJ. Is the pleth variability index a surrogate for pulse pressure variation in a pediatric population undergoing spine fusion? Paediatr Anaesth. 2012 Mar;22(3):250-5. doi: 10.1111/j.1460-9592.2011.03745.x. Epub 2011 Dec 6.

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