Clinical trial NCT02184169: Oxygen Consumption-based Assessments of Hemodynamics in Neonates Following Congenital Heart Surgery (Oxy-CAHN Study)
Official title: Oxygen Consumption-based Assessments of Hemodynamics in Neonates Following Congenital Heart Surgery (Oxy-CAHN Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transposition of the Great Vessels
Hypoplastic Left Heart Syndrome
Oxygen Consumption Based Assessment of Hemodynamics
Keywords: hemodynamics
neonatal
cardiac disease
congenital heart disease
volumetric oxygen consumption
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: General Electric
First posted: 2014-07-09
Enrollment: 27
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Oxygen Consumption
timeFrame: While mechanically ventilated, up to 14 days
Secondary outcomes:
measure: Computed Cardiac Index
timeFrame: While mechanically ventilated, up to 14 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: John Kheir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Stage 1 Palliation. J Am Heart Assoc. 2016 Nov 2;5(11):e003554. doi: 10.1161/JAHA.116.003554.