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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02184169

Acronym

Oxy-CAHN

Enrollment

Registered

2014-07-09

Start date

2012-12-31

Completion date

2019-01-29

Last updated

2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

hemodynamics, neonatal, cardiac disease, congenital heart disease, volumetric oxygen consumption

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.

Interventions

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

Breath to breath VO2 measurements

DEVICEEdwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr

Edwards continuous SVO2 measurement system

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 6 Months

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

Design outcomes

Primary

Measure	Time frame	Description
Oxygen Consumption	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

Measure	Time frame	Description
Computed Cardiac Index	While mechanically ventilated, up to 14 days	A calculated estimate of cardiac index/systemic blood flow based on the Fick principle.

Countries

United States

Participant flow

Participants by arm

Arm	Count
HLHS Patients undergoing palliative repair. General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system	21
TGA/IVS Surgical repair of TGA. General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system	6
Total	27

Baseline characteristics

Characteristic	Total	HLHS	TGA/IVS
Age, Categorical <=18 years	27 Participants	21 Participants	6 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age, Continuous	.1 years STANDARD_DEVIATION 0.1	.1 years STANDARD_DEVIATION 0.1	.1 years STANDARD_DEVIATION 0.1
Race and Ethnicity Not Collected	0 Participants	—	—
Region of Enrollment United States	27 Participants	21 Participants	6 Participants
Sex: Female, Male Female	13 Participants	11 Participants	2 Participants
Sex: Female, Male Male	14 Participants	10 Participants	4 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 21	0 / 6
other Total, other adverse events	0 / 21	0 / 6
serious Total, serious adverse events	0 / 21	0 / 6

Outcome results

Primary