NIRS in Neonatal Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven R Tosone MD, Emory University
ClinicalTrials.gov Identifier:
NCT00166101
First received: September 12, 2005
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

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
Hypoplastic Left Heart
Surgery

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.

  Eligibility

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166101

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

Publications:

Responsible Party: Steven R Tosone MD, Assistant Professor, Emory University
ClinicalTrials.gov 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:
pediatric
cardiac surgery

Additional relevant MeSH terms:
Hypoplastic Left Heart Syndrome
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 24, 2014