Accuracy of Pleth Variability Index (PVI) in Children

Scoliosis Clinical Trial

— PVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820845
• Other study ID #: PVI2013
• Status: Completed
• Phase: N/A
• First received: January 28, 2013
• Last updated: December 3, 2014
• Start date: December 2012
• Est. completion date: June 2014

Study information

• Verified date: December 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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.

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 %.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• Scoliosis surgery

• Age < 18 years

Exclusion Criteria:

• Heart or vascular Diseases

• Rectal abnormalities

• Kidney Failure

• Neuromuscular scoliosis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Scoliosis

Locations

Country	Name	City	State
France	Department of Anesthesiology, Robert Debre University Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	Plethysmographic Variability before each fluid challenge and percentage of variation in Indexed Stroke Volume during each fluid challenge.	Data will be used to assess the accuracy of Plethysmographic Variability Index in predicting fluid challenge.	During the intraoperative period.	No
Secondary	Indexed Stroke volume before each fluid challenge and percentage of variation in indexed Stroke volume during each fluid challenge.	Data will be used to assess the accuracy of indexed Stroke volume in predicting the response to fluid challenge.	During the intraoperative period	No