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Clinical Trials/NCT03701646
NCT03701646
Completed
Not Applicable

Comparing Non-invasive Cardiac Output Measurements by the ClearSight Hemodynamic Monitoring System to Thermodilution Measurements in Pediatric Patients Undergoing Cardiac Catheterization.

Nemours Children's Clinic1 site in 1 country10 target enrollmentNovember 2, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shock
Sponsor
Nemours Children's Clinic
Enrollment
10
Locations
1
Primary Endpoint
Measurement of non-invasive cardiac output or continuous blood pressure correlated to invasive measurements.
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
November 2, 2017
End Date
June 1, 2019
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Measurement of non-invasive cardiac output or continuous blood pressure correlated to invasive measurements.

Time Frame: 11/2/2017 - 6/1/2019

Comparison of measurements obtained by the ClearSight device compared to the invasive measurements will be used to evaluate whether the ClearSight device has any validity in pediatrics.

Study Sites (1)

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