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

Not Applicable

Completed

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

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

Registration Number: NCT02184169

Lead Sponsor: Boston Children's Hospital

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 27

Inclusion Criteria

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

Exclusion Criteria

Weight < 2 kg
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.
Patients on ECMO preoperatively
Clinically signiﬁcant tracheo-esophageal ﬁstula or known preoperative air leak

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HLHS	General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments	Patients undergoing palliative repair.
HLHS	Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr	Patients undergoing palliative repair.
TGA	General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments	Surgical repair of TGA.
TGA	Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr	Surgical repair of TGA.

Primary Outcome Measures

Name	Time	Method
Oxygen Consumption	While mechanically ventilated, up to 14 days	Oxygen consumption is the mass of oxygen gas consumed per minute, measured as the difference between oxygen mass inspired versus exhaled per minute.

Secondary Outcome Measures

Name	Time	Method
Computed Cardiac Index	While mechanically ventilated, up to 14 days	A calculated estimate of cardiac index/systemic blood flow based on the Fick principle.