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

Primary Purpose

Transposition of the Great Vessels, Hypoplastic Left Heart Syndrome, Oxygen Consumption Based Assessment of Hemodynamics

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Transposition of the Great Vessels focused on measuring hemodynamics, neonatal, cardiac disease, congenital heart disease, volumetric oxygen consumption

Eligibility Criteria

1 Day - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HLHS

TGA

Arm Description

Patients undergoing palliative repair.

Surgical repair of TGA.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 2, 2014
Last Updated
June 1, 2020
Sponsor
Boston Children's Hospital
Collaborators
General Electric
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1. Study Identification

Unique Protocol Identification Number
NCT02184169
Brief Title
Oxygen Consumption-based Assessments of Hemodynamics in Neonates Following Congenital Heart Surgery (Oxy-CAHN Study)
Acronym
Oxy-CAHN
Official Title
Oxygen Consumption-based Assessments of Hemodynamics in Neonates Following Congenital Heart Surgery (Oxy-CAHN Study)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 2012 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
January 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
General Electric

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HLHS
Arm Type
Experimental
Arm Description
Patients undergoing palliative repair.
Arm Title
TGA
Arm Type
Active Comparator
Arm Description
Surgical repair of TGA.
Intervention Type
Device
Intervention Name(s)
General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments
Intervention Description
Breath to breath VO2 measurements
Intervention Type
Device
Intervention Name(s)
Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr
Intervention Description
Edwards continuous SVO2 measurement system
Primary Outcome Measure Information:
Title
Oxygen Consumption
Description
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
Secondary Outcome Measure Information:
Title
Computed Cardiac Index
Description
A calculated estimate of cardiac index/systemic blood flow based on the Fick principle.
Time Frame
While mechanically ventilated, up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Kheir, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27806964
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.
Results Reference
result

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

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