The objective of this multicenter trial is to evaluate the efficacy and safety of the automatic oxygen delivery adjustment function in the AVEA ventilator in maintaining two target ranges of oxygen saturation in neonates receiving non-invasive…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
hypoxie en hyperoxie bij prematuriteit
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of time with SpO2 within the assigned target range
Secondary outcome
1. Oxygen saturation distribution
2. Fraction of Inspired Oxygen (FiO2)
3. Time with FiO2 at 21%
4. Oxygen saturation variability
5. Assessment of staff effort
6. Adherence to guidelines
7. Extended episodes with oxygen saturation below or above the target range
8. Incidence of episodes and time with oxygen saturation below the target range
9. Incidence of episodes and time with oxygen saturation above the target range
10. Assessment of response to SpO2 signal loss
11. Assessment of overshoot
Background summary
Hypoxia en hyperoxia are common events in preterm infants and can potentially
lead to organ damage. For this reason oxygen saturations are usually targeted
between 86-95%. In case of hypoxia, supplemental oxygen is started and manually
adjusted to keep the oxygen saturations within the target range. Because of
frequent fluctuations in oxygen saturations in preterm infants and the limited
time of nursing staff, manual adjustments in oxygen delivery will only result
in an oxygen saturation within the target in 50% of the time. Recent studies
have shown that this percentage can be improved safely by using automated
adjustment of the inspired oxygen via the ventilator. These results need to be
confirmed in a larger cohort of babies in different intensive care units, using
different oxygen saturation targets.
Study objective
The objective of this multicenter trial is to evaluate the efficacy and safety
of the automatic oxygen delivery adjustment function in the AVEA ventilator in
maintaining two target ranges of oxygen saturation in neonates receiving
non-invasive respiratory support in comparison to manual oxygen delivery
adjustment during routine clinical care.
Study design
Cross-over study in preterm infants with a gestational age between 24-32 weeks
on non-invasive support (nasal CPAP). Patients will be treated, in random
order, with automated oxygen delivery during 24 hours and manually adjusted
oxygen delivery during another 24 hours. Patients will be randomized to one of
two oxygen targets (89-91% or 91-95%).
Intervention
Automated adjustment of the inspired oxygen during 24 hours
Study burden and risks
There is no anticipated burden or risk for the patients participating in this
study. The non-invasive ventilators used, are standard of care and the only
adjustment made is the switching on and off of the automated inspired oxygen
function. Previous studies have shown no adverse effects but this needs to be
confirmed by the present study.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- born with a gestational age between 24 and 32 weeks.
- weight at study entry between 0.4 to 4 kilograms.
- receiving invasive mechanical ventilation or non-invasive respiratory support (NCPAP or NIPPV).
- receiving supplemental oxygen at the time of enrollment and for at least 18 hours during the previous 24 hours.
- expected to complete the 48 hour study period in the current form of respiratory support, i.e. invasive mechanical ventilation or non-invasive respiratory support.
- written informed parental consent.
Exclusion criteria
- major congenital anomalies
- arterial hypotension requiring vasopressor therapy within 48 hours prior to enrollment.
- culture proven sepsis within 72 hours prior to enrollment.
- if the attending physician deems participation in the study is not in the best interest of the infant
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42860.018.12 |