Accuracy of Pleth Variability Index (PVI) in Children (PVI)
|ClinicalTrials.gov Identifier: NCT01820845|
Recruitment Status : Completed
First Posted : March 29, 2013
Last Update Posted : December 4, 2014
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.
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Accuracy of Pleth Variability Index (PVI) in Predicting Response to Intravenous Fluid Load During Scoliosis Surgery in Children|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||June 2014|
|Cohort of children with scoliosis surgery|
- 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.
- 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.
- 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. [ Time Frame: During the intraoperative period ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01820845
|Department of Anesthesiology, Robert Debre University Hospital|
|Paris, France, 75019|