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Accuracy of Pleth Variability Index (PVI) in Children (PVI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01820845
First Posted: March 29, 2013
Last Update Posted: December 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
January 28, 2013
March 29, 2013
December 4, 2014
December 2012
December 2013   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01820845 on ClinicalTrials.gov Archive Site
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.
Same as current
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 ]
Same as current
 
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

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.

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 %.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Children undergoing scoliosis surgery
Scoliosis
Not Provided
Cohort of children with scoliosis surgery
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2014
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Scoliosis surgery
  • Age < 18 years

Exclusion Criteria:

  • Heart or vascular Diseases
  • Rectal abnormalities
  • Kidney Failure
  • Neuromuscular scoliosis
Sexes Eligible for Study: All
2 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01820845
PVI2013
No
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
December 2012