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

Does Near Infrared Spectroscopy Predict Low Cardiac Output State in Neonates and Infants Following Cardiac Surgery for Congenital Heart Disease?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01849120
Enrollment
35
Registered
2013-05-08
Start date
2013-05-31
Completion date
2015-09-30
Last updated
2017-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Keywords

near infrared spectroscopy (NIRS), EQUANOX Advance 8004CB probes, cerebral vascular circulation, peripheral perfusion

Brief summary

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.

Interventions

DEVICEEQUANOX 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.

Sponsors

Nonin Medical, Inc
CollaboratorINDUSTRY
Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
No

Inclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Venous lactate level48 hours post surgery

Secondary

MeasureTime frameDescription
Blood oxygen saturation level48 hours after surgeryOxygen saturation level will be measured by near-infrared spectroscopy (NIRS).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026