Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03701646 |
Other study ID # |
1146179 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 2, 2017 |
Est. completion date |
June 1, 2019 |
Study information
Verified date |
June 2023 |
Source |
Nemours Children's Clinic |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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. The 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.
Description:
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 are 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.