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Atrial Septal DefectNCT02276599

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

An observational study of Atrial Septal Defect, run by Brian Schloss at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 12 years
Conditions the study is for
Atrial Septal Defect
What is being tested?
Volume expansion
Type of treatment
Surgery or procedure
How many people
9 participants
Where
1 siteUnited States
Study dates
Feb 2015to 31 May 2018
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 1 year to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children undergoing cardiac catheterization for atrial septal defect.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

Other trials in United States

About this study

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.

Read the 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.

Being tested
Volume expansion
Medical subject headings
Heart Septal Defects, Atrial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Volume expansionProcedure or surgery

    Fluid bolus of 0.9% normal saline 10 mL/kg over 10 minutes

Study groups in NCT02276599
Study groupRoleWhat they receive
Cardiac catheterizationPatients with a diagnosis of atrial septal defect who are having a cardiac catheterization.
Receives: Procedure: Volume expansion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Pleth Variability Index

    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.

    Measured: 10 minutes

Secondary outcomes (2)
  1. Change in Cardiac Output

    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.

    Measured: 10 minutes

  2. Change in Stroke Volume

    Change in stroke volume following fluid bolus of 0.9% normal saline 10 mL/kg over 10 minutes, measured by echocardiogram.

    Measured: 10 mins

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2014 (estimated)
  2. Study startFeb 2015
  3. Primary completion7 Jul 2017
  4. Study completion31 May 2018

Why it stopped: Recruitment was too slow and data collected would not add to already published studies.

Resources

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
Case only
Time perspective
Prospective
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02276599
Sponsor's protocol ID
IRB14-00332
Status last verified
Oct 2018
First submitted
23 Oct 2014
Last updated
18 Oct 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Septal Defect, run by Brian Schloss 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 1 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: stopped early, as of the sponsor's last update on 18 Oct 2018. 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 was stopped early (reason given: Recruitment was too slow and data collected would not add to already published studies.). Results are not available in the source record.

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?

Change in Pleth Variability Index (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

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 18 Oct 2018.

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