Oxygen Consumption-based Assessments of Hemodynamics in Neonates Following Congenital Heart Surgery (Oxy-CAHN Study)
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/3/2019 |
| Start Date: | December 2012 |
| End Date: | January 29, 2019 |
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.
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.
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
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Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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