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

NCT01849120 | Completed

• 1 other identifier: 12-003690
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Venous lactate level

  48 hours post surgery

Secondary Outcomes (1)

• Blood oxygen saturation level

  48 hours after surgery

Study Arms (1)

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

Interventions

EQUANOX Advance 8004CB sensor DEVICE

The EQUANOX Advance 8004CB sensors placed in peripheral sites of neonates and infants will be used to detect peripheral perfusion and oxygen delivery.

Near-infrared spectroscopy (NIRS)

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

pediatric cardiac surgical patients that required cardiopulmonary bypass

You may qualify if:

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

You may not qualify if:

• weight \< 2 kg or \> 20 kg
• greater than 3 years of age
• thrombosed femoral arteries
• prior fasciotomies
• currently on extracorporeal membrane oxygenation (ECMO)

Sponsors & Collaborators

• Mayo Clinic: lead
• Nonin Medical, Inc: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• William Oliver, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: William Oliver, MD

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 8, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 14, 2017

Record last verified: 2017-04

Locations

US (1)