ClearSight Validation in Pediatrics
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Hospital |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Other |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 10/12/2018 |
| Start Date: | November 2, 2017 |
| End Date: | June 1, 2019 |
Comparing Non-invasive Cardiac Output Measurements by the ClearSight Hemodynamic Monitoring System to Thermodilution Measurements in Pediatric Patients Undergoing Cardiac Catheterization.
Specific aim 1: The specific aim of this study is to compare cardiac output measurements as
well as cardiac index, and stroke volume obtained via thermodilution during a cardiac
catheterization with data obtained by the ClearSight cardiac output monitoring system.
Specific aim 2: To compare arterial blood pressure measurements obtained by arterial line
with arterial waveform measurements obtained by the ClearSight System. Our hypothesis is:
Cardiac output measurements or arterial blood pressure measurements taken non-invasively with
the ClearSight system in pediatric patients who are either undergoing cardiac catheterization
or have an arterial line will correlate with cardiac output measurements taken by pulmonary
artery catheter thermodilution or arterial pressures measured by an arterial line.
well as cardiac index, and stroke volume obtained via thermodilution during a cardiac
catheterization with data obtained by the ClearSight cardiac output monitoring system.
Specific aim 2: To compare arterial blood pressure measurements obtained by arterial line
with arterial waveform measurements obtained by the ClearSight System. Our hypothesis is:
Cardiac output measurements or arterial blood pressure measurements taken non-invasively with
the ClearSight system in pediatric patients who are either undergoing cardiac catheterization
or have an arterial line will correlate with cardiac output measurements taken by pulmonary
artery catheter thermodilution or arterial pressures measured by an arterial line.
Specific aim number one: To compare cardiac output measurements obtained from the Clear Sight
cardiac output monitor with measurements obtained with thermodilution in the cardiac
catheterization laboratory. Significance: Currently, based on the Surviving Sepsis
guidelines, fluid administration is supposed to be guided by measurements of fluid
responsiveness. Currently, there very few ways to obtain measurements of fluid
responsiveness, such as cardiac output, stroke volume, and systemic vascular resistance
non-invasively. The invasive methods are no longer used in pediatrics, as the risk of placing
these invasive catheters is felt to outweigh the benefit of using the data provided by the
invasive cardiac output monitoring systems. Although the Clear Sight cardiac output
monitoring system has been validated in adults to measure cardiac output non-invasively, this
technology has not been evaluated in pediatrics. If the Clear Sight monitoring system is
shown to be accurate in pediatrics, it would safely provide data that could be lifesaving to
a pediatric patient in shock.
Specific aim number two: To compare the accuracy of the Clear Sight cardiac output monitor in
obtaining continuous blood pressure measurements non-invasively. Significance: Currently, the
only reliable method to continuously monitor blood pressure in critically ill patients is
with an invasive intra-arterial catheter. Placing this catheter carries risks with it,
including risk of infection as well as risk of intra-arterial thrombus which can lead to limb
ischemia. The Clear Sight cardiac output monitor has the technology to obtain continuous
blood pressure measurements non-invasively, although this technology has never been validated
in pediatric patients. Therefore, specific aim 1 is to determine if this technology can
reliably be used in pediatric patients. If it can, this would provide a method to obtain
continuous blood pressure measurements without the risk of an invasive catheter.
Hypothesis: Cardiac output and arterial blood pressure measurements taken non-invasively with
the ClearSight system in will correlate with cardiac output measurements taken by pulmonary
artery catheter thermodilution and arterial blood pressure measurements taken by arterial
line. This hypothesis is based on personal communications with the developers of this device.
cardiac output monitor with measurements obtained with thermodilution in the cardiac
catheterization laboratory. Significance: Currently, based on the Surviving Sepsis
guidelines, fluid administration is supposed to be guided by measurements of fluid
responsiveness. Currently, there very few ways to obtain measurements of fluid
responsiveness, such as cardiac output, stroke volume, and systemic vascular resistance
non-invasively. The invasive methods are no longer used in pediatrics, as the risk of placing
these invasive catheters is felt to outweigh the benefit of using the data provided by the
invasive cardiac output monitoring systems. Although the Clear Sight cardiac output
monitoring system has been validated in adults to measure cardiac output non-invasively, this
technology has not been evaluated in pediatrics. If the Clear Sight monitoring system is
shown to be accurate in pediatrics, it would safely provide data that could be lifesaving to
a pediatric patient in shock.
Specific aim number two: To compare the accuracy of the Clear Sight cardiac output monitor in
obtaining continuous blood pressure measurements non-invasively. Significance: Currently, the
only reliable method to continuously monitor blood pressure in critically ill patients is
with an invasive intra-arterial catheter. Placing this catheter carries risks with it,
including risk of infection as well as risk of intra-arterial thrombus which can lead to limb
ischemia. The Clear Sight cardiac output monitor has the technology to obtain continuous
blood pressure measurements non-invasively, although this technology has never been validated
in pediatric patients. Therefore, specific aim 1 is to determine if this technology can
reliably be used in pediatric patients. If it can, this would provide a method to obtain
continuous blood pressure measurements without the risk of an invasive catheter.
Hypothesis: Cardiac output and arterial blood pressure measurements taken non-invasively with
the ClearSight system in will correlate with cardiac output measurements taken by pulmonary
artery catheter thermodilution and arterial blood pressure measurements taken by arterial
line. This hypothesis is based on personal communications with the developers of this device.
Arm 1) Cardiac output measurements Patients will be selected as potential study
participants from the patients undergoing cardiac catheterization in the Nemours Cardiac
Center for medically indicated reasons.
Patients selected should meet the following criteria:
- Age 17 years old or younger
- Receiving a cardiac catheterization, including cardiac output measurement, for
clinical purposes, as determined by their cardiologist
- Hemodynamically stable with a scheduled non-emergent catheterization
Patients will be excluded from this study if:
- have digits too small to effectively fit into the smallest ClearSight finger probe
- Are hemodynamically unstable
Arm 2) Arterial blood pressure measurements
Patients will be selected as potential study participants from the patients admitted to the
pediatric intensive care unit and now requiring an arterial line for medically indicated
reasons.
Patients selected should meet the following criteria:
- Age 17 years old or younger
Patients will be excluded from this study if:
- Have digits too small to effectively fit into the smallest ClearSight finger probe
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