- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03701646
ClearSight Validation in Pediatrics
Comparing Non-invasive Cardiac Output Measurements by the ClearSight Hemodynamic Monitoring System to Thermodilution Measurements in Pediatric Patients Undergoing Cardiac Catheterization.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Delaware
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Wilmington, Delaware, United States, 19805
- Nemours A.I. duPont Hospital for Children
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
cardiac output
Pediatric patients requiring cardiac output measurement by thermodilution through cardiac catheterization.
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Clearsight Device is used to obtain non-invasive measurements to be correlated to standard invasive measurements.
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arterial line
Pediatric patients admitted to the ICU with a medically indicated arterial line.
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Clearsight Device is used to obtain non-invasive measurements to be correlated to standard invasive measurements.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of non-invasive cardiac output or continuous blood pressure correlated to invasive measurements.
Time Frame: 11/2/2017 - 6/1/2019
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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.
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11/2/2017 - 6/1/2019
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1146179
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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