ClearSight Validation in Pediatrics

NCT03701646 | Completed DMC FDA Device

• 1 other identifier: 1146179
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock; Hypotension and Shock

Outcome Measures

Primary Outcomes (1)

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

  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.

  11/2/2017 - 6/1/2019

Study Arms (2)

arterial line

Pediatric patients admitted to the ICU with a medically indicated arterial line.

Device: Measurement by Clearsight device

cardiac output

Pediatric patients requiring cardiac output measurement by thermodilution through cardiac catheterization.

Device: Measurement by Clearsight device

Interventions

Measurement by Clearsight device DEVICE

Clearsight Device is used to obtain non-invasive measurements to be correlated to standard invasive measurements.

arterial line; cardiac output

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients admitted to the ICU requiring an arterial line, or patients undergoing cardiac output measurements by cardiac catheterization by thermodilution.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours A.I. duPont Hospital for Children

Wilmington, Delaware, 19805, United States

Location

MeSH Terms

Conditions

Shock; Hypotension

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 10, 2018
• Study Start: November 2, 2017
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)