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

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. Identifier: NCT00994656
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : February 11, 2011
Children's Anesthesiology Associates, Ltd.
Information provided by:
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment
Scoliosis Spinal Fusion Device: Masimo multi-wavelength pulse co-oximeter

Detailed Description:

Spine fusion is an involved procedure during which patients are at risk for significant intra-operative blood loss. The resulting hypovolemia increases the fluctuations in arterial pressure associated with positive pressure ventilation. These respiratory induced arterial pressure variations (RIAPV) appear as cyclical peaks and troughs on the arterial waveform.

Different approaches have been used to quantify the RIAPV. One such approach has been to measure the pulse pressure variation (PPV), using invasive arterial monitoring. In previous studies, PPV has been shown to be a good indicator of fluid responsiveness intra-operatively, but this has not been specifically evaluated in patients undergoing spine fusion. This patient population is of particular interest because of their underlying scoliosis as well as their prone position during the operation. These two variables could potentially alter lung-thorax mechanics in a manner which may influence RIAPV, which is specifically determined by the interaction between intrathoracic pressure and venous filling of the heart. A second approach to quantifying RIAPV relies on non invasive technology initially developed by the Masimo Corporation for pulse oximetry. This parameter has been coined pleth variability index (PVI), as it specifically quantifies real time changes in the plethysmogram associated with respiration. PVI, which is based on arterial blood volume changes, is therefore analogous to PPV, which is derived from changes in arterial pressure. To date PVI has only been evaluated in adult patients undergoing cardiac surgery and the data suggest that it may be a useful indicator of fluid responsiveness.

Given the non-invasive and continuous nature of PVI, it is appealing for potential use as a bedside monitor to guide fluid resuscitation. However, photoplethysmography is known to be sensitive to noise due to motion, light and electrical interference. Furthermore, PVI is based upon a degree of quantitative evaluation of the photoplethysmogram that is the first of its kind. For these reasons, it is important to understand the limits of agreement between PVI and PPV before we can accept PVI as a non-invasive surrogate measurement. This study intends to evaluate PVI by analyzing it in relation to PPV. More specifically, paired measurements of PPV and PVI will be compared to determine the limits of agreement between the two parameters in patients undergoing spinal fusion.

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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is the Pleth Variability Index (PVI) a Useful Surrogate for Pulse Pressure Variations (PPV) in a Pediatric Population Undergoing Spine Fusion?
Study Start Date : October 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Group/Cohort Intervention/treatment
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
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.
Other Names:
  • Masimo Rainbow Set
  • pulse co-oximeter

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Inability to understand or read English to provide consent.

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 identifier (NCT number): NCT00994656

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United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Children's Anesthesiology Associates, Ltd.
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Principal Investigator: Jeffrey Feldman, MD Children's Hospital of Philadelphia

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Responsible Party: Jeffrey Feldman, MD, The Children's Hospital of Philadelphia Identifier: NCT00994656     History of Changes
Other Study ID Numbers: 09-007194
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: February 11, 2011
Last Verified: February 2011
Keywords provided by Children's Hospital of Philadelphia:
invasive procedures
Additional relevant MeSH terms:
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Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases