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ClearSight Validation in Pediatrics

NCT03701646 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2023-06-23

No results posted yet for this study

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

Interventions

DEVICE

Measurement by Clearsight device

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

Sponsors & Collaborators

  • Nemours Children's Clinic

    lead OTHER

Eligibility

Min Age
0 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-02
Primary Completion
2019-03-01
Completion
2019-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03701646 on ClinicalTrials.gov