Using Near-infrared Spectroscopy (NIRS) Monitor to Noninvasively Evaluate Hepatic Venous Saturation

June 29, 2015 updated by: Phoenix Children's Hospital
Clinical studies are required to validate the hepatic NIRS monitor with other regional and global hemodynamic parameters and to evaluate its clinical use for continuous non-invasive hemodynamic monitoring. Using newer NIRS sensors the correlation between hepatic regional oxygen saturation and hepatic venous oxygen saturation (SvHO2) needs to be determined. If found to correlate then the NIRS can be used to evaluate early liver transplant failure and/or hepatic artery thrombosis, used as an early marker for shock, and necrotizing enterocolitis, and finally used in the outpatient setting to evaluate patients with chronic liver pathologies. If our validation study finds that NIRS monitors are an appropriate marker of hepatic venous saturation then it will lead to further clinical studies.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All pediatric patients (0-18yrs) undergoing cardiac catheterization by the participating interventional cardiologist at Phoenix Children's Hospital will be recruited for this investigation

Description

Inclusion Criteria:

  • All pediatric patients (0-18yrs) undergoing cardiac catheterization by the participating interventional cardiologist at Phoenix Children's Hospital will be recruited for this investigation

Exclusion Criteria:

  • emergency catheterizations,
  • procedures in hemodynamically unstable patients,
  • patients with repeat catheterizations that have already enrolled in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cardiac Cath
All pediatric patients requiring cardiac catheterization who consent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of Hepatic Venous Saturation using NIRS
Time Frame: 5 minutes
The investigators strive to discover a noninvasive measure of hepatic venous saturation. The use of NIRS monitoring for global oxygen saturation has been used in the inpatient population. This project aims to use hepatic NIRS monitor as a surrogate marker for hepatic and splanchnic oxygenation.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phoenix Children's Hospital

Investigators

  • Principal Investigator: Rohit Rao, MD, Phoenix Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

November 30, 2012

First Submitted That Met QC Criteria

June 27, 2013

First Posted (Estimate)

July 3, 2013

Study Record Updates

Last Update Posted (Estimate)

June 30, 2015

Last Update Submitted That Met QC Criteria

June 29, 2015

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHNX-hNIRS-12-120

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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