Oxygen Titration in Preterm Infants to Manage Lung Disease
Conditions
Keywords
nasal cannula, high flow oxygen therapy, pulse oximetry
Brief summary
The overall objective of this study is to demonstrate that the IntellO2 device providing automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously breathing infants with fluctuating arterial blood oxygen saturation levels is safe and efficacious in the routine clinical environment. Specifically, it is hypothesized that the IntellO2 will perform as well or better than standard practice for maintaining infants' arterial blood oxygen saturation in a target range while minimizing the exposure to elevated levels of oxygen in the inspired gas.
Interventions
DEVICEIntellO2
Automated FiO2 regulator that responds to pulse oximetry measures
OTHERManual control
Standard practice of manually titrating FiO2 as needed.
Sponsors
Ashford and St. Peter's Hospitals NHS Trust
Oxford University Hospitals NHS Trust
Vapotherm, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Preterm infants being treated with high flow nasal cannula therapy 2. A need for supplemental oxygen as demonstrated by an required FiO2 \> 0.25 at enrollment 3. Requiring a flow rate of greater than 2 L/min such that the assumed inspired oxygen fraction matched delivered oxygen fraction (definition of HFNC).
Exclusion criteria
1. Major congenital abnormalities 2. Hemodynamic instability, defined as being outside of a normotensive range based on each infant's individual characteristics 3. Seizures 4. Ongoing sepsis 5. Meningitis 6. Clinician's concern regarding stability of the infant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent time in target range for oxygen saturation by pulse oximetry | 24 hrs |
Countries
United Kingdom
Outcome results
None listed