NIRS in Neonatal Cardiac Surgery
- Conditions
- SurgeryHypoplastic Left Heart
- Registration Number
- NCT00166101
- Lead Sponsor
- Emory University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- hypoplastic left heart
- requiring stage 1 palliation
- informed consent obtained
- does not have hypoplastic left heart
- is not having stage 1 palliation
- no informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States