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

NCT ID: NCT01849120

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-09-30

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

EQUANOX Advance 8004CB sensor

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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)

• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nonin Medical, Inc

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

William C. Oliver

William Oliver, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Oliver, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

12-003690

Identifier Type: -

Identifier Source: org_study_id