Oxygen Consumption-based Assessments of Hemodynamics in Neonates Following Congenital Heart Surgery (Oxy-CAHN Study)

Boston Children's Hospital

Status: Completed

Conditions: Transposition of the Great Vessels; Hypoplastic Left Heart Syndrome; Oxygen Consumption Based Assessment of Hemodynamics

Treatments: Device: Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr; Device: General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02184169

IRB-P00006630

Details and patient eligibility

About

The purpose of the Oxy-CAHN study is to improve the monitoring capabilities of newborn infants recovering from congenital heart surgery. Currently, we utilize important but unsophisticated measures, such as vital signs and lactate measurements, to monitor these patients. Although they are useful in categorizing patients as well or unwell, these signs currently lack the power quantify a patient's risk for cardiac arrest. More to the point, they are mostly indirect measures of what we really are assessing, which is tissue oxygen delivery.

Our group has significant expertise with devices which quantify the amount of oxygen that a baby consumes every minute. Historically, these values are more commonly used in combination with other measures to assess nutritional and metabolism status. In critically ill patients, however, the volume of oxygen consumed by a patient may be limited by the amount of oxygen their circulation delivers. This may represent a critical relationship, which has been previously described, but not exploited for the purpose of identifying patients with critically low oxygen delivery.

The aims of this study are therefore (1) to demonstrate that oxygen consumption can be safely and precisely measured continuously in newborns undergoing one of two common congenital heart surgeries, (2) to determine whether postoperative circulatory failure is associated with a precedent change in oxygen consumption, and (3) to determine whether the addition of the oxygen-based measurements (including oxygen consumption and venous oxygen saturations) to standardly measured parameters will add power in predicting which patients will experience postoperative circulatory failure.

If successful, this study may improve our capacity to non-invasively and continuously monitor patients following the highest risk congenital heart surgeries, and in the future,to create an algorithm which quantifies a patients risk for having a cardiac arrest. This may permit providers to intervene on these patients earlier, improving the morbidity and mortality associated with congenital heart disease.

Enrollment: 27 patients

Sex: All

Ages: 1 day to 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients from birth to 6 months of age
2. HLHS AND no prior operations AND planned S1P or HPOR d-TGA/IVS AND planned ASO
3. Written parental informed consent

Exclusion criteria

1. Weight < 2 kg

2. Disease specific A. HLHS patients: Infants whose surgical plan includes a neonatal biventricularrepair will be excluded.

   B. d-TGA/IVS patients: Newborns with any additional cardiac defect other than an atrial septal defect will be excluded.

3. Patients on ECMO preoperatively

4. Clinically significant tracheo-esophageal fistula or known preoperative air leak

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

HLHS

Experimental group

Description:

Patients undergoing palliative repair.

Treatment:

Device: Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr

Device: General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments

TGA

Active Comparator group

Description:

Surgical repair of TGA.

Treatment:

Device: Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr

Device: General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments