Using Near-infrared Spectroscopy (NIRS) Monitor to Noninvasively Evaluate Hepatic Venous Saturation
This trial is active, not recruiting.
|Conditions||congenital heart disease, arrhythmia|
|Sponsor||Phoenix Children's Hospital|
|Start date||June 2013|
|End date||June 2016|
|Trial size||100 participants|
|Trial identifier||NCT01891188, PHNX-hNIRS-12-120|
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.
All pediatric patients requiring cardiac catheterization who consent
Degree of Hepatic Venous Saturation using NIRS
time frame: 5 minutes
Male or female participants up to 18 years old.
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
|Official title||Using Near-infrared Spectroscopy (NIRS) Monitor to Noninvasively Evaluate Hepatic Venous Saturation|
|Principal investigator||Rohit Rao, MD|
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