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Accuracy of Pleth Variability Index (PVI) in Children

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Scoliosis

Study type

Observational

Funder types

Other

Identifiers

NCT01820845
PVI2013

Details and patient eligibility

About

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.

Full 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 %.

Enrollment

50 patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Scoliosis surgery
  • Age < 18 years

Exclusion criteria

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

Trial design

50 participants in 1 patient group

Cohort of children with scoliosis surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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