NCT01820845

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 29, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

January 28, 2013

Last Update Submit

December 3, 2014

Conditions

Scoliosis

Keywords

Plethysmographic Variability IndexEsophageal DopplerScoliosisChildrenAge < 18 yearsScheduled for Scoliosis Surgery

Outcome Measures

Primary Outcomes (1)

  • Plethysmographic Variability before each fluid challenge and percentage of variation in Indexed Stroke Volume during each fluid challenge.

    Data will be used to assess the accuracy of Plethysmographic Variability Index in predicting fluid challenge.

    During the intraoperative period.

Secondary Outcomes (1)

  • Indexed Stroke volume before each fluid challenge and percentage of variation in indexed Stroke volume during each fluid challenge.

    During the intraoperative period

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.

    During the intraoperative period

Study Arms (1)

Cohort of children with scoliosis surgery

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children undergoing scoliosis surgery

You may qualify if:

  • Scoliosis surgery
  • Age \< 18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Robert Debre University Hospital

Paris, Paris, 75019, France

Location

Related Publications (1)

  • Feldman JM, Sussman E, Singh D, Friedman BJ. Is the pleth variability index a surrogate for pulse pressure variation in a pediatric population undergoing spine fusion? Paediatr Anaesth. 2012 Mar;22(3):250-5. doi: 10.1111/j.1460-9592.2011.03745.x. Epub 2011 Dec 6.

    PMID: 22142032RESULT

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2013

First Posted

March 29, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

December 4, 2014

Record last verified: 2012-12

Locations

FR(1)