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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01891188
• Other study ID #: PHNX-hNIRS-12-120
• Status: Active, not recruiting
• Phase: N/A
• First received: November 30, 2012
• Last updated: June 29, 2015
• Start date: June 2013
• Est. completion date: July 2016

Study information

• Verified date: June 2013
• Source: Phoenix Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmia
• Congenital Heart Disease
• Heart Defects, Congenital

Locations

Country	Name	City	State
United States	Phoenix Children's Hospital	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Phoenix Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (31)

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Petros AJ, Heys R, Tasker RC, Fortune PM, Roberts I, Kiely E. Near infrared spectroscopy can detect changes in splanchnic oxygen delivery in neonates during apnoeic episodes. Eur J Pediatr. 1999 Feb;158(2):173-4. — View Citation

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Weiss M, Dullenkopf A, Kolarova A, Schulz G, Frey B, Baenziger O. Near-infrared spectroscopic cerebral oxygenation reading in neonates and infants is associated with central venous oxygen saturation. Paediatr Anaesth. 2005 Feb;15(2):102-9. — View Citation

Weiss M, Schulz G, Fasnacht M, Balmer C, Fischer JE, Gerber AC, Bucher HU, Baenziger O. Transcutaneously measured near-infrared spectroscopic liver tissue oxygenation does not correlate with hepatic venous oxygenation in children. Can J Anaesth. 2002 Oct;49(8):824-9. — View Citation

Weiss M, Schulz G, Teller I, Dullenkopf A, Kolarova A, Sailer H, Dillier CM, Bucher HU, Gerber AC, Baenziger O. Tissue oxygenation monitoring during major pediatric surgery using transcutaneous liver near infrared spectroscopy. Paediatr Anaesth. 2004 Dec;14(12):989-95. — View Citation

Wyatt JS, Cope M, Delpy DT, Wray S, Reynolds EO. Quantification of cerebral oxygenation and haemodynamics in sick newborn infants by near infrared spectrophotometry. Lancet. 1986 Nov 8;2(8515):1063-6. — View Citation

Yang W, Hafez T, Thompson CS, Mikhailidis DP, Davidson BR, Winslet MC, Seifalian AM. Direct measurement of hepatic tissue hypoxia by using a novel tcpO2/pCO2 monitoring system in comparison with near-infrared spectroscopy. Liver Int. 2003 Jun;23(3):163-70. — View Citation

Yoshitani K, Kawaguchi M, Iwata M, Sasaoka N, Inoue S, Kurumatani N, Furuya H. Comparison of changes in jugular venous bulb oxygen saturation and cerebral oxygen saturation during variations of haemoglobin concentration under propofol and sevoflurane anaesthesia. Br J Anaesth. 2005 Mar;94(3):341-6. Epub 2004 Dec 10. — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of Hepatic Venous Saturation using NIRS	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	No