Clinical trial NCT00166101: NIRS in Neonatal Cardiac Surgery
Official title: Near Infrared Spectroscopy Monitoring of Cerebral Oxygen Saturation in Neonatal Cardiac Surgery - Comparison With Common Methods of Estimating Adequate Systemic Perfusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoplastic Left Heart
Surgery
Keywords: pediatric
cardiac surgery
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates with Hypoplastic Left Heart Syndrome undergoing stage 1 palliation with the Norwood procedure.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Steven Tosone, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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. doi: 10.1097/00000542-200010000-00012.
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