NIRS in Neonatal Cardiac Surgery

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.

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Key information

Conditions

Hypoplastic Left Heart Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hypoplastic Left Heart Syndrome Surgery

Age range

1 day–1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Near Infrared Spectroscopy Monitoring of Cerebral Oxygen Saturation in Neonatal Cardiac Surgery - Comparison With Common Methods of Estimating Adequate Systemic Perfusion

Important dates

Study start: 2002
Primary completion: 2008
Study completion: 2008
First posted: Sep 14, 2005
Registry last updated: Nov 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed