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A Prospective Investigation of Pleth Variability Index (PVI) as a Dynamic Parameter of Fluid Responsiveness in Children

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ClinicalTrials.gov Identifier: NCT02276599
Recruitment Status : Terminated (Recruitment was too slow and data collected would not add to already published studies.)
First Posted : October 28, 2014
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Brian Schloss, Nationwide Children's Hospital

Brief Summary:
This study is designed to investigate the ability of pleth variability index (PVI) to non-invasively predict fluid responsiveness in mechanically ventilated children. Patients undergoing atrial septal defect (ASD) repair in the cardiac catheterization suite will be recruited for this study. These patients are ideal candidates because very few deviations will be made from standard clinical practice. All patients will already be under general anesthesia, mechanically ventilated, monitored with pulse oximetry, and provided with intravenous fluid to compensate for their nil per os (NPO) fluid deficit. The only deviation from clinical practice will include an abbreviated echocardiographic exam, application of the Masimo pulse oximeter, and measurement of CO via a thermodilution catheter by the interventional cardiologist.

Condition or disease Intervention/treatment
Atrial Septal Defect Procedure: Volume expansion

Detailed Description:

Background: Hypovolemia is a frequent cause of circulatory failure in anesthetized and critically ill children. Fluid boluses are the first line of treatment aimed at optimizing stroke volume and ultimately improving oxygen delivery. A patient whose stroke volume significantly increases as a result of a fluid bolus is deemed 'fluid responsive'. Traditional parameters of circulatory status (e.g. blood pressure, heart rate, central venous pressure) have been shown to be ineffective at predicting fluid responsiveness. Dynamic parameters of fluid responsiveness, such as pulse pressure variation (PPV) and stroke volume variation (SVV), reflect hemodynamic changes secondary to intermittent positive pressure ventilation. These indices have proven to be superior to the traditional static measures of circulatory status in predicting fluid responsiveness. Furthermore, the use of these dynamic parameters in a goal-directed fashion has been shown to improve outcome in high risk, adult surgical patients. As such, there is increasing interest in using dynamic parameters to guide fluid resuscitation in mechanically ventilated infants and children. Unfortunately, there is a paucity of literature examining the validity of these dynamic parameters in children. The need for arterial vascular access, which is less common in small children, has also limited the ability to investigate these parameters. Recently, a non-invasive dynamic parameter has been developed examining the plethysmographic waveform from a pulse oximeter. The pleth variability index (PVI) represents the dynamic changes in hemodynamic performance that occur during the respiratory cycle. Studies of PVI in adults have shown it to be a reliable predictor of fluid responsiveness. However, conclusive data in children are lacking.

Hypothesis: This study is designed to investigate the ability of PVI to non-invasively predict fluid responsiveness in mechanically ventilated children. The hypothesis is that a higher PVI will predict significant stroke volume increases in response to a fluid bolus in mechanically ventilated children.

Methods: The study population will consist of 20 children undergoing cardiac catheterization who will have normal (non-shunted) physiology at the conclusion of the procedure, ages 1-12 years. All subjects will receive a PVI measurement as well as a stroke volume measurement via transthoracic echocardiography. Subsequent volume expansion will be achieved with an intravenous bolus of 10 mL/kg of isotonic crystalloid (normal saline) administered over 10 minutes. After completion of the bolus, an additional PVI measurement and stroke volume measurement will be obtained.

Significance: Hypovolemia is a significant cause of harm in anesthetized and critically ill infants and children. In order to successfully resuscitate these patients, we must gain a better understanding of how to optimize cardiac output and oxygen delivery. A non-invasive monitor which indicates stroke volume responsiveness has the potential to better guide fluid resuscitation and improve outcomes.

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Investigation of Pleth Variability Index (PVI) as a Dynamic Parameter of Fluid Responsiveness in Children
Actual Study Start Date : February 2015
Actual Primary Completion Date : July 7, 2017
Actual Study Completion Date : May 31, 2018

Group/Cohort Intervention/treatment
Cardiac catheterization
Patients with a diagnosis of atrial septal defect who are having a cardiac catheterization.
Procedure: Volume expansion
Fluid bolus of 0.9% normal saline 10 mL/kg over 10 minutes




Primary Outcome Measures :
  1. Change in Pleth Variability Index [ Time Frame: 10 minutes ]
    Change in Pleth Variability Index following fluid bolus of 0.9% normal saline 10 mL/kg over 10 minutes, measured by Masimo Radical-7 monitor.


Secondary Outcome Measures :
  1. Change in Cardiac Output [ Time Frame: 10 minutes ]
    Change in cardiac output following fluid bolus of 0.9% normal saline 10 mL/kg over 10 minutes, measured by interventional radiologist during cardiac catheterization.

  2. Change in Stroke Volume [ Time Frame: 10 mins ]
    Change in stroke volume following fluid bolus of 0.9% normal saline 10 mL/kg over 10 minutes, measured by echocardiogram.



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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children undergoing cardiac catheterization for atrial septal defect.
Criteria

Inclusion Criteria:

  • Children undergoing cardiac catheterization who will have normal (non-shunted) physiology at the conclusion of the procedure.

Exclusion Criteria:

  • Patients with additional congenital heart abnormalities, cardiac arrhythmias, ventricular dysfunction, and known pulmonary disease.

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 ClinicalTrials.gov identifier (NCT number): NCT02276599


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Brian Schloss
Investigators
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Principal Investigator: Brian Schloss, MD Nationwide Children's Hospital
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Responsible Party: Brian Schloss, Assistant Professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02276599    
Other Study ID Numbers: IRB14-00332
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities