ScoliosisPVINCT01820845
Accuracy of Pleth Variability Index (PVI) in Children
An observational study of Scoliosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Scoliosis
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Jun 2014
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children undergoing scoliosis surgery
Who may be able to join
- Scoliosis surgery
- Age < 18 years
Who cannot join
- Heart or vascular Diseases
- Rectal abnormalities
- Kidney Failure
- Neuromuscular scoliosis
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Anesthesiology, Robert Debre University Hospital
Paris, Paris, 75019
About this study
Official title: Accuracy of Pleth Variability Index (PVI) in Predicting Response to Intravenous Fluid Load During Scoliosis Surgery in Children
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.
Read the detailed description
The goal of the present study is to assess the validity of PVI in predicting the response to a fluid challenge during scoliosis surgery in children.
During this observational non-interventional study, each fluid challenge will be monitored by esophageal Doppler and PVI (Massimo Radical 5).
Anesthesia, surgery and intraoperative fluid administration id standardized according to our clinical protocol.
An increase in indexed Stroke Volume (iSV) by more than 15 % will define the positive response to the fluid challenge.
Fluid challenges will be performed in the supine position and in the prone position.
Statistical analysis will performed using the Receiving Operator Characteristics (ROC) curve with determination of the gray-zone allowing an error tolerance of 10 %.
- Conditions
- Scoliosis
- Keywords
- Plethysmographic Variability Index, Esophageal Doppler, Scoliosis, Children, Age < 18 years, Scheduled for Scoliosis Surgery
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort of children with scoliosis surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Data will be used to assess the accuracy of indexed Stroke volume in predicting the response to fluid challenge.
Measured: During the intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820845
- Sponsor's protocol ID
- PVI2013
- Acronym
- PVI
- Status last verified
- Dec 2012
- First submitted
- 28 Jan 2013
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22142032
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Pleth Variability Index (PVI) in Predicting Response to Intravenous Fluid Load During Scoliosis Surgery in Children
- ClinicalTrials.gov ID
- NCT01820845
- Acronym / sponsor ID
- PVI / PVI2013
- Conditions
- Scoliosis
- Keywords
- Plethysmographic Variability Index, Esophageal Doppler, Scoliosis, Children, Age < 18 years, Scheduled for Scoliosis Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 29 Mar 2013 (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.
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.
Detailed description
The goal of the present study is to assess the validity of PVI in predicting the response to a fluid challenge during scoliosis surgery in children.
During this observational non-interventional study, each fluid challenge will be monitored by esophageal Doppler and PVI (Massimo Radical 5).
Anesthesia, surgery and intraoperative fluid administration id standardized according to our clinical protocol.
An increase in indexed Stroke Volume (iSV) by more than 15 % will define the positive response to the fluid challenge.
Fluid challenges will be performed in the supine position and in the prone position.
Statistical analysis will performed using the Receiving Operator Characteristics (ROC) curve with determination of the gray-zone allowing an error tolerance of 10 %.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of children with scoliosis surgery | – | – |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children undergoing scoliosis surgery
Key inclusion criteria (2 listed)
- Scoliosis surgery
- Age < 18 years
Key exclusion criteria (4 listed)
- Heart or vascular Diseases
- Rectal abnormalities
- Kidney Failure
- Neuromuscular scoliosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plethysmographic Variability before each fluid challenge and percentage of variation in Indexed Stroke Volume during each fluid challenge.
Time frame: During the intraoperative period.
Data will be used to assess the accuracy of Plethysmographic Variability Index in predicting fluid challenge.
1 secondary outcome
Indexed Stroke volume before each fluid challenge and percentage of variation in indexed Stroke volume during each fluid challenge.
Time frame: During the intraoperative period
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 4 Dec 2014.
- Results publication: PubMed 22142032Feldman 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.
Related trials for Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 inclusion and 4 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 4 Dec 2014. 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 France. 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.
What does the primary outcome measure?
Plethysmographic Variability before each fluid challenge and percentage of variation in Indexed Stroke Volume during each fluid challenge. (time frame: During the intraoperative period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01820845, which also lists 1 linked publication.
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 4 Dec 2014.