Using Near-infrared Spectroscopy (NIRS) Monitor to Noninvasively Evaluate Hepatic Venous Saturation
NCT ID: NCT01891188
Last Updated: 2015-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2013-06-30
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cardiac Cath
All pediatric patients requiring cardiac catheterization who consent
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* procedures in hemodynamically unstable patients,
* patients with repeat catheterizations that have already enrolled in the study
1 Day
18 Years
ALL
No
Sponsors
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Phoenix Children's Hospital
OTHER
Responsible Party
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Principal Investigators
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Rohit Rao, MD
Role: PRINCIPAL_INVESTIGATOR
Phoenix Children's Hospital
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Countries
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References
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FDA 510K Clearances. (2001) Somanetics Corp Adult/Pediatric Cerebral Oximeter Model 5100.http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm093461.htm
Marin T, Moore J. Understanding near-infrared spectroscopy. Adv Neonatal Care. 2011 Dec;11(6):382-8. doi: 10.1097/ANC.0b013e3182337ebb.
Hayashida M, Kin N, Tomioka T, Orii R, Sekiyama H, Usui H, Chinzei M, Hanaoka K. Cerebral ischaemia during cardiac surgery in children detected by combined monitoring of BIS and near-infrared spectroscopy. Br J Anaesth. 2004 May;92(5):662-9. doi: 10.1093/bja/aeh120. Epub 2004 Mar 19.
Hoffman GM, Stuth EA, Jaquiss RD, Vanderwal PL, Staudt SR, Troshynski TJ, Ghanayem NS, Tweddell JS. Changes in cerebral and somatic oxygenation during stage 1 palliation of hypoplastic left heart syndrome using continuous regional cerebral perfusion. J Thorac Cardiovasc Surg. 2004 Jan;127(1):223-33. doi: 10.1016/j.jtcvs.2003.08.021.
Nollert G, Jonas RA, Reichart B. Optimizing cerebral oxygenation during cardiac surgery: a review of experimental and clinical investigations with near infrared spectrophotometry. Thorac Cardiovasc Surg. 2000 Aug;48(4):247-53. doi: 10.1055/s-2000-6895.
Watzman HM, Kurth CD, Montenegro LM, Rome J, Steven JM, Nicolson SC. Arterial and venous contributions to near-infrared cerebral oximetry. Anesthesiology. 2000 Oct;93(4):947-53. doi: 10.1097/00000542-200010000-00012.
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. doi: 10.1016/s0140-6736(86)90467-8.
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. doi: 10.1093/bja/aei046. Epub 2004 Dec 10.
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. doi: 10.1007/s004310051046. No abstract available.
Nagdyman N, Fleck T, Barth S, Abdul-Khaliq H, Stiller B, Ewert P, Huebler M, Kuppe H, Lange PE. Relation of cerebral tissue oxygenation index to central venous oxygen saturation in children. Intensive Care Med. 2004 Mar;30(3):468-71. doi: 10.1007/s00134-003-2101-8. Epub 2004 Jan 13.
Schulz G, Weiss M, Bauersfeld U, Teller J, Haensse D, Bucher HU, Baenziger O. Liver tissue oxygenation as measured by near-infrared spectroscopy in the critically ill child in correlation with central venous oxygen saturation. Intensive Care Med. 2002 Feb;28(2):184-9. doi: 10.1007/s00134-001-1182-5. Epub 2002 Jan 12.
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. doi: 10.1111/j.1460-9592.2005.01404.x.
Nollert G, Mohnle P, Tassani-Prell P, Uttner I, Borasio GD, Schmoeckel M, Reichart B. Postoperative neuropsychological dysfunction and cerebral oxygenation during cardiac surgery. Thorac Cardiovasc Surg. 1995 Oct;43(5):260-4. doi: 10.1055/s-2007-1013224.
Berens RJ, Stuth EA, Robertson FA, Jaquiss RD, Hoffman GM, Troshynski TJ, Staudt SR, Cava JR, Tweddell JS, Bert Litwin S. Near infrared spectroscopy monitoring during pediatric aortic coarctation repair. Paediatr Anaesth. 2006 Jul;16(7):777-81. doi: 10.1111/j.1460-9592.2006.01956.x.
Tsuji M, Saul JP, du Plessis A, Eichenwald E, Sobh J, Crocker R, Volpe JJ. Cerebral intravascular oxygenation correlates with mean arterial pressure in critically ill premature infants. Pediatrics. 2000 Oct;106(4):625-32. doi: 10.1542/peds.106.4.625.
Beilman GJ, Groehler KE, Lazaron V, Ortner JP. Near-infrared spectroscopy measurement of regional tissue oxyhemoglobin saturation during hemorrhagic shock. Shock. 1999 Sep;12(3):196-200. doi: 10.1097/00024382-199909000-00005.
Rhee P, Langdale L, Mock C, Gentilello LM. Near-infrared spectroscopy: continuous measurement of cytochrome oxidation during hemorrhagic shock. Crit Care Med. 1997 Jan;25(1):166-70. doi: 10.1097/00003246-199701000-00030.
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. doi: 10.1034/j.1600-0676.2003.00818.x.
El-Desoky AE, Jiao LR, Havlik R, Habib N, Davidson BR, Seifalian AM. Measurement of hepatic tissue hypoxia using near infrared spectroscopy: comparison with hepatic vein oxygen partial pressure. Eur Surg Res. 2000;32(4):207-14. doi: 10.1159/000008766.
El-Desoky AE, Seifalian AM, Davidson BR. Effect of graded hypoxia on hepatic tissue oxygenation measured by near infrared spectroscopy. J Hepatol. 1999 Jul;31(1):71-6. doi: 10.1016/s0168-8278(99)80165-2.
Teller J, Wolf M, Keel M, Bucher HU, Fanconi S, Baenziger O. Can near infrared spectroscopy of the liver monitor tissue oxygenation? Eur J Pediatr. 2000 Jul;159(7):549. doi: 10.1007/s004310051334.
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. doi: 10.1111/j.1460-9592.2004.01362.x.
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. doi: 10.1007/BF03017416.
Teller J, Schwendener K, Wolf M, Keel M, Bucher HU, Fanconi S, Baenziger O. Continuous monitoring of liver oxygenation with near infrared spectroscopy during naso-gastric tube feeding in neonates. Schweiz Med Wochenschr. 2000 May 6;130(18):652-6.
Ceppa EP, Fuh KC, Bulkley GB. Mesenteric hemodynamic response to circulatory shock. Curr Opin Crit Care. 2003 Apr;9(2):127-32. doi: 10.1097/00075198-200304000-00008.
Kinoshita G, Washizu M, Motoyoshi S, Breznock EM. Effects of hypovolemic shock and reperfusion on liver blood flow in the dog. J Vet Med Sci. 1995 Aug;57(4):703-8. doi: 10.1292/jvms.57.703.
Lautt WW. The 1995 Ciba-Geigy Award Lecture. Intrinsic regulation of hepatic blood flow. Can J Physiol Pharmacol. 1996 Mar;74(3):223-33.
Lautt WW, McQuaker JE. Maintenance of hepatic arterial blood flow during hemorrhage is mediated by adenosine. Can J Physiol Pharmacol. 1989 Sep;67(9):1023-8. doi: 10.1139/y89-161.
Jakob SM, Tenhunen JJ, Laitinen S, Heino A, Alhava E, Takala J. Effects of systemic arterial hypoperfusion on splanchnic hemodynamics and hepatic arterial buffer response in pigs. Am J Physiol Gastrointest Liver Physiol. 2001 May;280(5):G819-27. doi: 10.1152/ajpgi.2001.280.5.G819.
Eipel C, Abshagen K, Vollmar B. Regulation of hepatic blood flow: the hepatic arterial buffer response revisited. World J Gastroenterol. 2010 Dec 28;16(48):6046-57. doi: 10.3748/wjg.v16.i48.6046.
Ortmann LA, Fontenot EE, Seib PM, Eble BK, Brown R, Bhutta AT. Use of near-infrared spectroscopy for estimation of renal oxygenation in children with heart disease. Pediatr Cardiol. 2011 Aug;32(6):748-53. doi: 10.1007/s00246-011-9960-5. Epub 2011 Mar 29.
Other Identifiers
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PHNX-hNIRS-12-120
Identifier Type: -
Identifier Source: org_study_id