NIRS Predict Low Cardiac Output State in Neonates and Infants in Cardiac Surgery
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | Any - 3 |
Updated: | 4/21/2016 |
Start Date: | May 2013 |
End Date: | September 2015 |
Does Near Infrared Spectroscopy Predict Low Cardiac Output State in Neonates and Infants Following Cardiac Surgery for Congenital Heart Disease?
Neonates and infants that have cardiac surgery with cardiopulmonary bypass (CPB) for
congenital heart disease are at great risk for experiencing life-threatening low cardiac
output syndrome (LCOS) in the first 24 hours after surgery. The poor perfusion and
inadequate oxygen delivery that occurs may result in multiple organ failure and death. It is
LCOS that is responsible for the majority of early postoperative deaths in this population
of neonates and infants. Improved pediatric probes placed in peripheral locations using near
infrared spectroscopy (NIRS) may permit continuous monitoring of venous saturations
reflecting overall perfusion and oxygen balance in the tissues. Following parental or
guardian consent, 30 neonates and infants scheduled to undergo surgery for congenital heart
disease will be enrolled. At the end of surgery, four EQUANOX Advance 8004CB probes will be
placed on the flank, lower extremities and the forehead. Continuous NIRS saturations will be
monitored and stored for analysis. Point of care (POC) lactates will be obtained after
admission to the intensive care unit (ICU) every 2 hours for the first 24 hours
postoperatively, then once at 48 hours. The association between NIRS oxygen saturation and
POC lactate values will be assessed using mixed linear models taking into account the
repeated measures design. Exploratory analyses will be performed to assess whether NIRS
oxygen saturation is associated with outcomes such as days in ICU, adverse events and
mortality.
The ability to use noninvasive, continuous monitoring for overall perfusion and cardiac
output will allow better and earlier therapy for neonates and infants following cardiac
surgery.
congenital heart disease are at great risk for experiencing life-threatening low cardiac
output syndrome (LCOS) in the first 24 hours after surgery. The poor perfusion and
inadequate oxygen delivery that occurs may result in multiple organ failure and death. It is
LCOS that is responsible for the majority of early postoperative deaths in this population
of neonates and infants. Improved pediatric probes placed in peripheral locations using near
infrared spectroscopy (NIRS) may permit continuous monitoring of venous saturations
reflecting overall perfusion and oxygen balance in the tissues. Following parental or
guardian consent, 30 neonates and infants scheduled to undergo surgery for congenital heart
disease will be enrolled. At the end of surgery, four EQUANOX Advance 8004CB probes will be
placed on the flank, lower extremities and the forehead. Continuous NIRS saturations will be
monitored and stored for analysis. Point of care (POC) lactates will be obtained after
admission to the intensive care unit (ICU) every 2 hours for the first 24 hours
postoperatively, then once at 48 hours. The association between NIRS oxygen saturation and
POC lactate values will be assessed using mixed linear models taking into account the
repeated measures design. Exploratory analyses will be performed to assess whether NIRS
oxygen saturation is associated with outcomes such as days in ICU, adverse events and
mortality.
The ability to use noninvasive, continuous monitoring for overall perfusion and cardiac
output will allow better and earlier therapy for neonates and infants following cardiac
surgery.
Inclusion:
- pediatric patients 0-3 years of age
- scheduled to undergo cardiopulmonary bypass surgery (CPB) for repair of congenital
heart defects
Exclusion:
- weight < 2 kg or > 20 kg
- greater than 3 years of age
- thrombosed femoral arteries
- prior fasciotomies
- currently on extracorporeal membrane oxygenation (ECMO)
We found this trial at
1
site
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
Click here to add this to my saved trials