ClearSight Validation in Pediatrics

Completed

• Conditions: Hypotension and Shock; Shock
• Interventions: Device: Measurement by Clearsight device

• Registration Number: NCT03701646
• Lead Sponsor: Nemours Children's Clinic

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.

Study Timeline

• Study Start: 2017-11-02
• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-08
• Study First Posted: 2018-10-10
• Primary Completion: 2019-03-01
• Study Completion: 2019-06-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cardiac output	Measurement by Clearsight device	Pediatric patients requiring cardiac output measurement by thermodilution through cardiac catheterization.
arterial line	Measurement by Clearsight device	Pediatric patients admitted to the ICU with a medically indicated arterial line.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Nemours A.I. duPont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States