Accuracy of Pleth Variability Index (PVI) in Children

Accuracy of Pleth Variability Index (PVI) in Predicting Response to Intravenous Fluid Load During Scoliosis Surgery in Children

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01820845

Acronym

PVI

Enrollment

Registered

2013-03-29

Start date

2012-12-31

Completion date

2014-06-30

Last updated

2014-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis

Keywords

Plethysmographic Variability Index, Esophageal Doppler, Scoliosis, Children, Age < 18 years, Scheduled for Scoliosis Surgery

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 %.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 18 Years

Healthy volunteers

Inclusion criteria

* Scoliosis surgery * Age \< 18 years

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame
Heart rate, Arterial pressure (systolic, diastolic and mean), End tidal CO2 concentration, Tidal volume, respiratory frequency, Airway pressure, Sevoflurane or desflurane concentrations before and after each fluid challenge.	During the intraoperative period

Countries

France

Outcome results