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NIRS in Neonatal Cardiac Surgery

Emory University logo

Emory University

Status

Completed

Conditions

Surgery
Hypoplastic Left Heart

Study type

Observational

Funder types

Other

Identifiers

NCT00166101
459-2002

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

1 day to 1 year old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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