NIRS Predict Low Cardiac Output State in Neonates and Infants in Cardiac Surgery

This study has been completed.
Nonin Medical, Inc
Information provided by (Responsible Party):
William C. Oliver, Mayo Clinic Identifier:
First received: May 6, 2013
Last updated: April 11, 2016
Last verified: April 2016

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.

Condition Intervention
Congenital Heart Disease
Device: EQUANOX Advance 8004CB sensor

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Does Near Infrared Spectroscopy Predict Low Cardiac Output State in Neonates and Infants Following Cardiac Surgery for Congenital Heart Disease?

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Venous lactate level [ Time Frame: 48 hours post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood oxygen saturation level [ Time Frame: 48 hours after surgery ] [ Designated as safety issue: No ]
    Oxygen saturation level will be measured by near-infrared spectroscopy (NIRS).

Enrollment: 35
Study Start Date: May 2013
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Near-infrared spectroscopy (NIRS)
After cardiac surgery, all subjects will have EQUANOX Advance 8004CB sensors applied to peripheral sites (left and right calf and side of abdomen).
Device: EQUANOX Advance 8004CB sensor
The EQUANOX Advance 8004CB sensors placed in peripheral sites of neonates and infants will be used to detect peripheral perfusion and oxygen delivery.


Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • pediatric patients 0-3 years of age
  • scheduled to undergo cardiopulmonary bypass surgery (CPB) for repair of congenital heart defects


  • weight < 2 kg or > 20 kg
  • greater than 3 years of age
  • thrombosed femoral arteries
  • prior fasciotomies
  • currently on extracorporeal membrane oxygenation (ECMO)
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Please refer to this study by its identifier: NCT01849120

United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Nonin Medical, Inc
Principal Investigator: William Oliver, MD Mayo Clinic
  More Information

Responsible Party: William C. Oliver, William Oliver, MD, Mayo Clinic Identifier: NCT01849120     History of Changes
Other Study ID Numbers: 12-003690 
Study First Received: May 6, 2013
Last Updated: April 11, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
near infrared spectroscopy (NIRS)
EQUANOX Advance 8004CB probes
cerebral vascular circulation
peripheral perfusion

Additional relevant MeSH terms:
Cardiac Output, Low
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Signs and Symptoms processed this record on May 26, 2016