Clinical trial NCT01820845: Accuracy of Pleth Variability Index (PVI) in Children
Official title: Accuracy of Pleth Variability Index (PVI) in Predicting Response to Intravenous Fluid Load During Scoliosis Surgery in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scoliosis
Keywords: Plethysmographic Variability Index
Esophageal Doppler
Scoliosis
Children
Age < 18 years
Scheduled for Scoliosis Surgery
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-03-29
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children undergoing 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 %.

Eligibility criteria: Inclusion Criteria:

* Scoliosis surgery
* Age \< 18 years

Exclusion Criteria:

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

Primary outcomes:
measure: Plethysmographic Variability before each fluid challenge and percentage of variation in Indexed Stroke Volume during each fluid challenge.
timeFrame: During the intraoperative period.
Secondary outcomes:
measure: Indexed Stroke volume before each fluid challenge and percentage of variation in indexed Stroke volume during each fluid challenge.
timeFrame: During the intraoperative period
Other outcomes:
measure: 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.
timeFrame: During the intraoperative period
Locations:
city: Paris
country: France
facility: Department of Anesthesiology, Robert Debre University Hospital
Study officials:
References:
citation: 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.