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Completed

NCT Number: NCT02184169

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments

Device

Breath to breath VO2 measurements

Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr

Device

Edwards continuous SVO2 measurement system

Primary outcomes

  1. Oxygen Consumption

    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.

Secondary outcomes

  1. Computed Cardiac Index

    Time frame: While mechanically ventilated, up to 14 days

    A calculated estimate of cardiac index/systemic blood flow based on the Fick principle.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • General Electric

Registry information

Acronym: Oxy-CAHN

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Jul 9, 2014
Registry last updated
Jun 4, 2020

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.

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