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

Hypoplastic Left Heart Syndrome Clinical Trial

— Oxy-CAHN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02184169
• Other study ID #: IRB-P00006630
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: January 29, 2019

Study information

• Verified date: June 2020
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 29, 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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 speci?c 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 signi?cant tracheo-esophageal ?stula or known preoperative air leak

Related Conditions & MeSH terms

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

Intervention

Device:
• General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments
Breath to breath VO2 measurements
• Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr
Edwards continuous SVO2 measurement system

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children’s Hospital	General Electric

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mills KI, Kaza AK, Walsh BK, Bond HC, Ford M, Wypij D, Thiagarajan RR, Almodovar MC, Quinonez LG, Baird CW, Emani SE, Pigula FA, DiNardo JA, Kheir JN. Phosphodiesterase Inhibitor-Based Vasodilation Improves Oxygen Delivery and Clinical Outcomes Following — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen Consumption	Oxygen consumption is the mass of oxygen gas consumed per minute, measured as the difference between oxygen mass inspired versus exhaled per minute.	While mechanically ventilated, up to 14 days
Secondary	Computed Cardiac Index	A calculated estimate of cardiac index/systemic blood flow based on the Fick principle.	While mechanically ventilated, up to 14 days