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

• Conditions: Congenital Heart Disease; Arrhythmia

• Registration Number: NCT01891188
• Lead Sponsor: Phoenix Children's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-30
• Status Verified: 2013-06
• Study Start: 2013-06
• Study First Submitted QC: 2013-06-27
• Study First Posted: 2013-07-03
• Last Update Submitted: 2015-06-29
• Last Update Posted: 2015-06-30
• Primary Completion: 2016-06
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of Hepatic Venous Saturation using NIRS	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.

Trial Locations

Locations (1)

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States