Congenital Heart Defect, Neonatal Respiratory Failure
Conditions
Brief summary
The measurement of how much oxygen a baby consumes provides important information about the health of the baby, and of how much energy they are consuming. Currently, there is no device which measures either oxygen consumption, or another variable that depends on oxygen consumption - resting energy expenditure - in neonates or infants. Our group has developed a new device which can attach to any ventilator and measures these two variables with accuracy in the preclinical setting, including in rodents as small as severely preterm infants. The purpose of this study is to compare measurements of oxygen consumption and energy expenditure in neonates using this device and comparing it with a gold standard which is rarely used, a Douglas bag method in which expired gas is collected and later analyzed.
Interventions
DEVICEMeasurement of oxygen consumption and caloric expenditure
This study will involve an \ 1 hour, single point in time measurement of oxygen consumption, carbon dioxide production, resting energy expenditure, and respiratory quotient using two methods while patients are breathing an FiO2 of 40%. These measurements will be measured using the novel, responsive device and compared with gas collected simultaneously collected from a Douglas bag.
Sponsors
Innovision
Boston Children's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No
Inclusion criteria
. 1. Mechanically ventilated neonates and infants (\<1 year of age). 2. Inpatients in the cardiac or neonatal intensive care unit at Boston Children's Hospital. 3. Assent of patient's intensive care attending physician, including agreement to place patient on 40% oxygen for up to 60 minutes. 4. Written parental informed consent.
Exclusion criteria
. 1. Hemodynamic or respiratory instability. 2. Patients on extracorporeal membrane oxygenation support. 3. Clinically significant tracheo-esophageal fistula 4. Measured endotracheal tube leak \>20% (i.e. difference between inspiratory and expiratory tidal volumes)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxygen consumption | 1 hour |
| Carbon dioxide production | 1 hour |
| Respiratory quotient | 1 hour |
| Resting energy expenditure | 1 hour |
Countries
United States
Outcome results
None listed