ScoliosisNCT00994656
Is Pleth Variability Index (PVI) a Surrogate for Pulse Pressure Variations (PPV) in Pediatric Spine Fusion (SF) Surgery?
An observational study of Scoliosis and Spinal Fusion, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Scoliosis, Spinal Fusion
- What is being tested?
- Masimo multi-wavelength pulse co-oximeter
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects will be selected from those having posterior spinal fusion surgery at The Children's Hospital of Philadelphia.
Who may be able to join
- 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.
Who cannot join
- Inability to understand or read English to provide consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Is the Pleth Variability Index (PVI) a Useful Surrogate for Pulse Pressure Variations (PPV) in a Pediatric Population Undergoing Spine Fusion?
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.
Read the 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.
- Conditions
- Scoliosis, Spinal Fusion
- Being tested
- Masimo multi-wavelength pulse co-oximeter
- Keywords
- invasive procedures, hypovolemia
- Medical subject headings
- Scoliosis, Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo multi-wavelength pulse co-oximeterDevice
Also called Masimo Rainbow Set, 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Masimo multi-wavelength pulse co-oximeter |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Anesthesiology Associates, Ltd.
- Investigators
- Jeffrey Feldman, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994656
- Sponsor's protocol ID
- 09-007194
- Status last verified
- Feb 2011
- First submitted
- 12 Oct 2009
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Pleth Variability Index (PVI) a Useful Surrogate for Pulse Pressure Variations (PPV) in a Pediatric Population Undergoing Spine Fusion?
- ClinicalTrials.gov ID
- NCT00994656
- Acronym / sponsor ID
- 09-007194
- Conditions
- Scoliosis, Spinal Fusion
- Keywords
- invasive procedures, hypovolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Children's Anesthesiology Associates, Ltd.
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| posterior spinal fusion subject | – | Device: Masimo multi-wavelength pulse co-oximeterSubject will have a history of either idiopathic or neuromuscular scoliosis who is now scheduled to have a posterior spinal fusion. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects will be selected from those having posterior spinal fusion surgery at The Children's Hospital of Philadelphia.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability to understand or read English to provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Masimo multi-wavelength pulse co-oximeterAlso: Masimo Rainbow Set, pulse co-oximeterSubjects 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. | Device | posterior spinal fusion subject |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Feldman, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis and Spinal Fusion, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2011.