Accuracy of Pleth Variability Index (PVI) in Children
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Accuracy of Pleth Variability Index (PVI) in Predicting Response to Intravenous Fluid Load During Scoliosis Surgery in Children|
- Plethysmographic Variability before each fluid challenge and percentage of variation in Indexed Stroke Volume during each fluid challenge. [ Time Frame: During the intraoperative period. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||June 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Cohort of children with scoliosis surgery|
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 %.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01820845
|Contact: Souhayl DAHMANI, MD,PhDemail@example.com|
|Department of Anesthesiology, Robert Debre University Hospital||Recruiting|
|Paris, France, 75019|
|Contact: Souhayl DAHMANI, MD,PhD 0033140034183 firstname.lastname@example.org|