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Sponsored by: |
Emory University |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00166101 |
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.
Condition |
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Hypoplastic Left Heart Surgery |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Near Infrared Spectroscopy Monitoring of Cerebral Oxygen Saturation in Neonatal Cardiac Surgery - Comparison With Common Methods of Estimating Adequate Systemic Perfusion |
Estimated Enrollment: | 25 |
Study Start Date: | August 2002 |
Estimated Study Completion Date: | August 2008 |
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.
Ages Eligible for Study: | up to 1 Year |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 459-2002 |
Study First Received: | September 12, 2005 |
Last Updated: | October 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00166101 History of Changes |
Health Authority: | United States: Institutional Review Board |
pediatric cardiac surgery |
Heart Diseases Cardiovascular Abnormalities Hypoplastic Left Heart Syndrome Congenital Abnormalities Heart Defects, Congenital |
Heart Diseases Cardiovascular Abnormalities Hypoplastic Left Heart Syndrome |
Cardiovascular Diseases Congenital Abnormalities Heart Defects, Congenital |