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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: May 8, 2013
Last Update Posted: April 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Nonin Medical, Inc
Information provided by (Responsible Party):
William C. Oliver, Mayo Clinic

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: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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 William C. Oliver, Mayo Clinic:

Primary Outcome Measures:
  • Venous lactate level [ Time Frame: 48 hours post surgery ]

Secondary Outcome Measures:
  • Blood oxygen saturation level [ Time Frame: 48 hours after surgery ]
    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)
Groups/Cohorts Assigned Interventions
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.


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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pediatric cardiac surgical patients that required cardiopulmonary bypass


  • 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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT01849120     History of Changes
Other Study ID Numbers: 12-003690
First Submitted: May 6, 2013
First Posted: May 8, 2013
Last Update Posted: April 14, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiac Output, Low
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Signs and Symptoms