Is Pleth Variability Index (PVI) a Surrogate for Pulse Pressure Variations (PPV) in Pediatric Spine Fusion (SF) Surgery?

NCT00994656 | Completed

• 1 other identifier: 09-007194
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Spine fusion is an involved procedure during which patients are at risk for significant intra-operative blood loss.This study will compare 2 ways of determining fluid status and response to fluid administration. One way is to measure the changes in the arterial wave form from the special IV that is usually placed in an artery (PPV). The second way is to use a non-invasive method of a finger probe that measures changes in the plethysmogram or the pleth variability index (PVI). No actual patient treatments will be based on these values during surgery.

Conditions

Scoliosis; Spinal Fusion

Keywords

invasive procedures; hypovolemia

Study Arms (1)

posterior spinal fusion subject

Subject will have a history of either idiopathic or neuromuscular scoliosis who is now scheduled to have a posterior spinal fusion.

Device: Masimo multi-wavelength pulse co-oximeter

Interventions

Masimo multi-wavelength pulse co-oximeter DEVICE

Subjects will have a finger probe that will measure the pleth variability index. They will also have an arterial line (as standard of care) from which arterial pulse tracings will be obtained.

Also known as: Masimo Rainbow Set, pulse co-oximeter

posterior spinal fusion subject

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be selected from those having posterior spinal fusion surgery at The Children's Hospital of Philadelphia.

You may qualify if:

• Males or females age 8 to 18 years inclusive.
• History of idiopathic or neuromuscular scoliosis.
• Scheduled for posterior spinal fusion.
• Parental/guardian permission (informed consent) and if appropriate, child assent.

You may not qualify if:

• Inability to understand or read English to provide consent.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Children's Anesthesiology Associates, Ltd.: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Scoliosis; Hypovolemia

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey Feldman, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 12, 2009
• First Posted: October 14, 2009
• Study Start: October 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: February 11, 2011

Record last verified: 2011-02

Locations

US (1)