Surgery Clinical Trial
Official title:
Near Infrared Spectroscopy Monitoring of Cerebral Oxygen Saturation in Neonatal Cardiac Surgery - Comparison With Common Methods of Estimating Adequate Systemic Perfusion
Verified date | November 2012 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
Due to the small size of infants and the use of bypass machines, physicians have difficulty assessing whether the infant's brain and body is getting enough oxygen during heart surgery. This study compares continuous monitoring via the NIRS (Near Infrared Spectroscopy) to the traditional methods of determining oxygen saturation.
Status | Completed |
Enrollment | 25 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 1 Year |
Eligibility |
Inclusion Criteria: - hypoplastic left heart - requiring stage 1 palliation - informed consent obtained Exclusion Criteria: - does not have hypoplastic left heart - is not having stage 1 palliation - no informed consent |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Adcock LM, Wafelman LS, Hegemier S, Moise AA, Speer ME, Contant CF, Goddard-Finegold J. Neonatal intensive care applications of near-infrared spectroscopy. Clin Perinatol. 1999 Dec;26(4):893-903, ix. Review. — View Citation
Daubeney PE, Pilkington SN, Janke E, Charlton GA, Smith DC, Webber SA. Cerebral oxygenation measured by near-infrared spectroscopy: comparison with jugular bulb oximetry. Ann Thorac Surg. 1996 Mar;61(3):930-4. — View Citation
Daubeney PE, Smith DC, Pilkington SN, Lamb RK, Monro JL, Tsang VT, Livesey SA, Webber SA. Cerebral oxygenation during paediatric cardiac surgery: identification of vulnerable periods using near infrared spectroscopy. Eur J Cardiothorac Surg. 1998 Apr;13(4):370-7. — View Citation
du Plessis AJ, Newburger J, Jonas RA, Hickey P, Naruse H, Tsuji M, Walsh A, Walter G, Wypij D, Volpe JJ. Cerebral oxygen supply and utilization during infant cardiac surgery. Ann Neurol. 1995 Apr;37(4):488-97. — View Citation
Kurth CD, Steven JM, Nicolson SC, Chance B, Delivoria-Papadopoulos M. Kinetics of cerebral deoxygenation during deep hypothermic circulatory arrest in neonates. Anesthesiology. 1992 Oct;77(4):656-61. — View Citation
Kurth CD, Steven JM, Nicolson SC. Cerebral oxygenation during pediatric cardiac surgery using deep hypothermic circulatory arrest. Anesthesiology. 1995 Jan;82(1):74-82. — View Citation
Madsen PL, Secher NH. Near-infrared oximetry of the brain. Prog Neurobiol. 1999 Aug;58(6):541-60. Review. — View Citation
Nollert G, Shin'oka T, Nagashima M, Shum-Tim D. Cerebral oxygenation during cardiopulmonary bypass in children. J Thorac Cardiovasc Surg. 1997 Nov;114(5):871-3. — View Citation
Wardle SP, Yoxall CW, Weindling AM. Determinants of cerebral fractional oxygen extraction using near infrared spectroscopy in preterm neonates. J Cereb Blood Flow Metab. 2000 Feb;20(2):272-9. — View Citation
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. — View Citation
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