NIRS in Neonatal Cardiac Surgery

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00166101
• Other study ID #: 459-2002
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: November 9, 2012
• Start date: August 2002
• Est. completion date: August 2008

Study information

• Verified date: November 2012
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

One of the limiting factors in treating infants undergoing cardiac surgery is the difficulty in assessing systemic perfusion with accuracy. At Children's Healthcare of Atlanta, Near-infrared Spectroscopy (NIRS) is available, but has never been studied. In patients undergoing first stage palliation (Norwood) for hypoplastic left heart, routine management will be utilized in addition to the NIRS monitor. The following will be documented pre- and post-bypass, then every 4 hours for 24 hours after admission to the Cardiac Intensive Care Unit:NIRS readings, Lactic acid levels,mixed venous saturations,hemoglobin, hematocrit, arterial blood gases, heart rate, blood pressure, central venous pressure, left atrium pressure,core temperature, toe temperature, pulse oximeter reading, urine output, ventilator settings, inotropic levels. All the data will be entered into a database and analyzed.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypoplastic Left Heart
• Hypoplastic Left Heart Syndrome
• Surgery

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

References & Publications (10)

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