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Completed

NCT Number: NCT01820845

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.

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Key information

Conditions

Scoliosis Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology, Robert Debre University Hospital

Paris, 75019, France

About this study

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 %.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scoliosis surgery
  • Age < 18 years

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: PVI

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Mar 29, 2013
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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