Optimising Oxygenation of Preterm infants during Respiratory support by fine-tuning Automatic TItration of Oxyge
Recruiting
- Conditions
- Respiratory distressventilation10028971
- Registration Number
- NL-OMON50861
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 27
Inclusion Criteria
Born between 24-32 weeks of gestation receiving respiratory support and
supplemental oxygen (at least 25%), with written informed parental consent.
Exclusion Criteria
Major congenital anomalies or arterial hypotension requiring vasopressor
therapy within 48 hours prior to enrolment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To compare the effect of two target ranges (91%-95% and 92%-96%) while on<br /><br>automated oxygen control while using the OxyGenie controller on the frequency<br /><br>of hypoxic episodes (SpO2 <80% for 1 second or longer).</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To compare the effect of two target ranges (91%-95% and 92%-96%) while on<br /><br>automated oxygen control by using the OxyGenie controller on parameters of<br /><br>oxygenation:<br /><br>a) Distribution of oxygen saturation (the SpO2 histogram).<br /><br>b) Proportion of time in hypoxaemia and hyperoxaemia (varying degrees).<br /><br>c) Frequency and duration of hypoxaemic and hyperoxaemic episodes, and of<br /><br>bradycardia. (defined as a heartrate < 100 for more than 10 seconds)<br /><br>d) Frequency of FiO2 adjustments during automated control, both made by the<br /><br>controller, and by bedside staff to over-ride the automated system.<br /><br>e) Overall oxygen exposure (average measured FiO2) .<br /><br>- To compare the effect of two SpO2 target ranges (91%-95% and 92%-96%) during<br /><br>automated oxygen control on alarm pressure for the caregiver:<br /><br>Frequency of SpO2 alarms on smartphone<br /><br>Total duration of SpO2 alarms on smartphone</p><br>