NIRS in Neonatal Cardiac Surgery

This study has been completed.
Information provided by (Responsible Party):
Steven R Tosone MD, Emory University Identifier:
First received: September 12, 2005
Last updated: November 9, 2012
Last verified: November 2012
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.

Hypoplastic Left Heart

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Near Infrared Spectroscopy Monitoring of Cerebral Oxygen Saturation in Neonatal Cardiac Surgery - Comparison With Common Methods of Estimating Adequate Systemic Perfusion

Resource links provided by NLM:

Further study details as provided by Emory University:

Enrollment: 25
Study Start Date: August 2002
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neonates with Hypoplastic Left Heart Syndrome undergoing stage 1 palliation with the Norwood procedure.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00166101

United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Principal Investigator: Steven Tosone, MD Emory University
  More Information


Responsible Party: Steven R Tosone MD, Assistant Professor, Emory University Identifier: NCT00166101     History of Changes
Other Study ID Numbers: 459-2002
Study First Received: September 12, 2005
Last Updated: November 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
cardiac surgery

Additional relevant MeSH terms:
Hypoplastic Left Heart Syndrome
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases processed this record on November 25, 2015