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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
  Purpose

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.


Condition
Scoliosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Accuracy of Pleth Variability Index (PVI) in Predicting Response to Intravenous Fluid Load During Scoliosis Surgery in Children

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: December 2012
Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort of children with scoliosis surgery

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 %.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children undergoing scoliosis surgery
Criteria

Inclusion Criteria:

  • Scoliosis surgery
  • Age < 18 years

Exclusion Criteria:

  • Heart or vascular Diseases
  • Rectal abnormalities
  • Kidney Failure
  • Neuromuscular scoliosis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01820845


Locations
France
Department of Anesthesiology, Robert Debre University Hospital
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01820845     History of Changes
Other Study ID Numbers: PVI2013
First Submitted: January 28, 2013
First Posted: March 29, 2013
Last Update Posted: December 4, 2014
Last Verified: December 2012

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Plethysmographic Variability Index
Esophageal Doppler
Scoliosis
Children
Age < 18 years
Scheduled for Scoliosis Surgery

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases