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

December 3, 2014 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

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 %.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Department of Anesthesiology, Robert Debre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children undergoing scoliosis surgery

Description

Inclusion Criteria:

  • Scoliosis surgery
  • Age < 18 years

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cohort of children with scoliosis surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the intraoperative period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the intraoperative period

Other Outcome Measures

Outcome Measure
Time Frame
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
During the intraoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 28, 2013

First Submitted That Met QC Criteria

March 26, 2013

First Posted (Estimate)

March 29, 2013

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PVI2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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