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Accuracy of Pleth Variability Index (PVI) in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01820845
First received: January 28, 2013
Last updated: January 29, 2014
Last verified: December 2012
  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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2012
Estimated 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

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01820845

Contacts
Contact: Souhayl DAHMANI, MD,PhD 0033140034183 souhayl.dahmani@rdb.aphp.fr

Locations
France
Department of Anesthesiology, Robert Debre University Hospital Recruiting
Paris, France, 75019
Contact: Souhayl DAHMANI, MD,PhD    0033140034183    souhayl.dahmani@rdb.aphp.fr   
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
Study First Received: January 28, 2013
Last Updated: January 29, 2014
Health Authority: France: Institutional Ethical Committee

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
Bone Diseases
Musculoskeletal Diseases
Spinal Curvatures
Spinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014