Boston Children's Hospital
Boston, Massachusetts, 02115, United States
NCT Number: NCT02184169
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.
Looking for future studies?
Notify Me1 day–6 month
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
B. d-TGA/IVS patients: Newborns with any additional cardiac defect other than an atrial septal defect will be excluded.
Breath to breath VO2 measurements
Edwards continuous SVO2 measurement system
Time frame: 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.
Time frame: While mechanically ventilated, up to 14 days
A calculated estimate of cardiac index/systemic blood flow based on the Fick principle.
Boston Children's Hospital
Other
Acronym: Oxy-CAHN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00513240
Aortic Arch Hypoplasia or Interruption, Cardiovascular Abnormalities
Houston, Texas, United States
View Trial DetailsNCT04452188
Aortopulmonary Septal Defect, Cardiopulmonary Bypass
Ann Arbor, Michigan, United States
View Trial DetailsNCT04056416
Behavior, Cardiovascular Abnormalities
Edmonton, Alberta, Canada
View Trial DetailsNCT03431480
Cardiovascular Abnormalities, Cardiovascular Diseases
Melbourne, Victoria, Australia
View Trial Details