Oxygen Consumption-based Assessments of Hemodynamics in Neonates Following Congenital Heart Surgery (Oxy-CAHN Study)
Oxy-CAHN
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 2, 2014
CompletedFirst Posted
Study publicly available on registry
July 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 29, 2019
CompletedResults Posted
Study results publicly available
June 4, 2020
CompletedJune 4, 2020
June 1, 2020
6 years
July 2, 2014
January 16, 2020
June 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Computed Cardiac Index
While mechanically ventilated, up to 14 days
Study Arms (2)
HLHS
EXPERIMENTALPatients undergoing palliative repair.
TGA
ACTIVE COMPARATORSurgical repair of TGA.
Interventions
Breath to breath VO2 measurements
Edwards continuous SVO2 measurement system
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Children's Hospitallead
- General Electriccollaborator
Study Sites (1)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Related 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 Stage 1 Palliation. J Am Heart Assoc. 2016 Nov 2;5(11):e003554. doi: 10.1161/JAHA.116.003554.
PMID: 27806964RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Kheir
- Organization
- Boston Childrens Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
John Kheir, MD
Boston Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
July 2, 2014
First Posted
July 9, 2014
Study Start
December 1, 2012
Primary Completion
December 1, 2018
Study Completion
January 29, 2019
Last Updated
June 4, 2020
Results First Posted
June 4, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share