- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00994656
Is Pleth Variability Index (PVI) a Surrogate for Pulse Pressure Variations (PPV) in Pediatric Spine Fusion (SF) Surgery?
Is the Pleth Variability Index (PVI) a Useful Surrogate for Pulse Pressure Variations (PPV) in a Pediatric Population Undergoing Spine Fusion?
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- The Children's Hospital of Philadelphia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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:
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jeffrey Feldman, MD, Children's Hospital of Philadelphia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-007194
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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